The alert was issued to pharmacists, physicians, hospital risk managers and consumers, and advised those parties to be aware that the change may have clinical significance in some situations. Because of the decrease in potency, health care providers should monitor the anticoagulant effect of the drug in patients as more heparin may be needed to achieve and maintain the desired level of anticoagulation in some patients.

The FDA is working with the new manufacturers of heparin to ensure that an appropriate identifier is placed on heparin made under the new USP monograph. Most manufacturers will place an “N” next to the lot number. The agency also is working with heparin manufacturers to study the impact of this variation in potency, and will make the results of the study available soon.

Consumers should be aware that their doctor may prescribe a higher dose of heparin that normally received, or patients may receive more monitoring after receiving doses of heparin than previously.

The changes will start affecting the heparin used in the healthcare settings on or after October 8, 2009. Patients should contact their healthcare provider if they have any questions or concerns about their heparin treatment.

SOURCE: Heparin Recall › FDA notifies public about changes to heparin potency

POGO is an independent nonprofit group that investigates and exposes corruption and other misconduct in order to achieve a more effective, accountable, open and ethical federal government. The organization has spoken out previously about the FDA and its handling of contaminated food and drugs, such as the tainted heparin scandal of 2007. Now it is asking questions about the contaminated pre-filled heparin and saline syringes manufactured and sold by AM2PAT.

In a letter to FDA commissioner Margaret A. Hamburg, the organization said the FDA missed chances to act before a contaminated lot of 74,000 syringes were shipped by AM2PAT to hospitals and health care centers. Earlier this year, two officials with AM2PAT were sentenced to prison after pleading guilty to crimes related to the contamination.

“Why did the FDA fail in its duty to keep a dangerous medical product, AM2PAT’s syringes, off the market?” asks POGO in its letter. “We believe that part of the reason is a culture within the FDA that habitually maintains a relationship with manufacturers that is too collegial and too tolerant. There is a reluctance by the FDA to take corrective action stronger than a Warning Letter, even when stronger action is clearly indicated, as it was at several points in the history of the AM2PAT case. There is an additional reason for the FDA’s failure: the grossly inadequate resources available to the FDA for inspection and enforcement. This is mainly a budgetary problem that can, of course, be solved only by the White House and Congress.”

POGO says that the FDA knew of AM2PAT’s failures for more than a year but has issued no public statement about the failures. “The silence on the part of the FDA officials would by itself indicate the need for an investigation and report by the Inspector General.”

SOURCE: Heparin Recall › Watchdog group pressures FDA about contaminated syringes

Two deaths and one illness earlier this month following the injection of heparin in patients at a Lewes, Delaware, hospital sent chills through the nation. Could this be a repeat of the deadly contamination that harmed so many in 2007? The vials of heparin were traced back to Baxter, however these doses were manufactured in Ohio, not China, the drug maker contends.

Last year’s OSCS contaminant caused victims to suffer severely low blood pressure. This new reaction involves intracranial bleeding. Investigations by both Baxter and the Food and Drug Administration (FDA) followed and early findings indicate there is no trace of OSCS in the heparin used. Now Baxter says it is confident that the events at the Delaware hospital were “isolated, institution-specific issues, unrelated to the quality of Baxter’s heparin premix product,” a Baxter spokesperson told the Reuters news organization.

According to Baxter, it obtained samples from the lot in question as well as lots produced before and after the lot in question. Testing on those lots confirmed that the product’s formulation was within specifications and met all requirements. The FDA backed up Baxter’s contention: “We don’t see a quality problem with the product,” an FDA spokesperson said.

SOURCE: Heparin Recall › Baxter says it’s not responsible for recent heparin deaths, illness

She already has Senator Edward M. Kennedy’s support. “Her expertise is valuable for problems we now face, such as combating food-borne illness, cooperating with other agencies to address the new flu outbreak and drug-resistant diseases, and protecting our food and drug supplies,” Sen. Kennedy said in a statement for the Health, Education, Labor, and Pensions Committee hearing.

If confirmed, one of Dr. Hamburg’s many priorities will be to detangle the mess left behind from last year’s contaminated heparin scandal, in which batches of tainted heparin manufactured in China made their way into the United States. Those bad batches killed more than 80 people and sickened hundreds more. An investigation resulted in the FDA’s admission that it did not have the resources or the funding to adequately inspect foreign food and drug manufacturing companies.

The agency’s handling of the heparin scandal is currently under review by the Government Accountability Office, and congressional leaders are not letting up on their insistence that the FDA make better provisions to ensure the food and drugs imported into the US are safe.

“It is abundantly clear that the agency needs strong, new leadership to improve morale and make it once again the world class agency that Americans can trust to protect the health of their families,” Sen. Kennedy wrote. “I’m very pleased, therefore, that President Obama has nominated Dr. Margaret Hamburg to lead the FDA as its new Commissioner.”

SOURCE: Heparin Recall › Obama’s pick for FDA commissioner wants to restore trust in agency

Rep. Joe Barton

The FDA has previously claimed the raw heparin originated from a manufacturing company in China and was purposefully contaminated with a man-made chemical, over-sulfated chondroitin sulfate, OSCS. The Chinese government disagrees.

Barton, a ranking member of the House Energy and Commerce Committee, has long championed the effort to resolve the heparin scandal by scrutinizing the FDA’s investigation into the case and the subsequent recall. He has previously argued that the agency misrepresented deaths tied to the heparin and didn’t thoroughly investigate the matter. He also has demanded answers on why the FDA took six months to seize lots of the contaminated heparin from an Ohio agency that still had the tainted drug in stock.

In his latest inquiry, Barton wants to know if the FDA has tracked the contamination back to the source. He also asked what action the Chinese government has taken in the matter and whether anyone in China has been held accountable.

Products imported from China have been in the spotlight in recent years as reports of more tainted foods, drugs and toys have entered the U.S. and injured people. The FDA has been working to expand its inspections of foreign imports in part by opening offices overseas. The first of these offices opened late last year in China.

SOURCE: Heparin Recall › Congressman demands answers on tainted heparin scandal

Rivaroxaban, a pill marketed in Europe as Xarelto, showed to be more effective than the anticoagulant heparin, while presenting no more side effects than heparin. Side effects of heparin and rivaroxaban include the risk of internal bleeding. Another benefit of rivaroxaban is that it does not need constant monitoring like another popular blood thinner, warfarin. Heparin is administered intravenously while warfarin is a pill taken orally.

Pharmaceutical companies have long been working on safer and easier alternatives to heparin and warfarin, especially since the tainted heparin scandal last year where more than 80 Americans died and hundreds more were made sick after receiving injections of batches of heparin that had been laced with oversulfated chondroitin sulfate (OSCS), a contaminant that mimics heparin but can cause serious allergic reactions in humans.

The FDA is expected to make a decision whether to approve rivaroxaban by May 28. If approved, rivaroxaban would be the first oral blood thinner approved since the FDA approved warfarin in 1954, according to Forbes.

“We appreciate the thoroughness of the advisory committee’s review, and we will continue to work with the FDA as they finalize their review,” Dr. Peter DiBattiste, vice president of Johnson & Johnson Pharmaceutical Research and Development, said in a prepared statement.

SOURCE: Heparin Recall › FDA panel recommends agency approval of heparin alternative

Sharfstein made headlines in 2007 when he convinced the FDA to restrict the use of over-the-counter children’s cough and cold medicines based on evidence they can cause serious health complications and even death in children.

If there is one government agency that needs overhauling, it is clearly the FDA. The agency has been under scrutiny for the past few years over contaminated food and drug products that have harmed and even killed Americans.

The agency is still feeling the repercussions from the tainted heparin scandal. Last year more than 80 Americans died and several more were made seriously ill after receiving injections of specific batches of the blood thinner that had been manufactured in a China plant. Those batches were found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a contaminant that mimics heparin but can cause serious allergic reactions.

Following the revelation, the FDA admitted that it simply did not have manpower to properly inspect foreign food and drug manufacturing plants. Since then the FDA has taken measures to step up its inspections by opening field offices overseas. The first three offices opened late last year in China.

The FDA employs more than 11,000 employees and an annual operating budget of $2 billion.

SOURCE: Heparin Recall › Hamburg, Sharfstein to head troubled FDA

Last March, after more than 100 people died and hundreds more were sickened after being given the tainted heparin, an investigation found that heparin manufactured in Baxter’s China plant had been contaminated with oversulfated chondroitin sulfate (OSCS). OSCS mimics heparin and can cost substantially less to produce – $9 compared to $900. However, OSCS can cause serious allergic reactions which can lead to death.

The lawsuit states, “The recalled heparin was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses. Baxter placed tens of thousands of patients, including the Plaintiffs, at unnecessary risk of serious injury and/or death.”

It also claims Baxter wrongfully allowed the heparin to be placed on the market and “breached its express warranties that heparin had no dangerous side effects and that its ingredients were manufactured in a plant in accordance with FDA regulations,” according to the report.

The six-count suit seeks a judgment of more than $300,000 plus costs and other relief.

SOURCE: Heparin Recall › Class action lawsuit filed against Baxter over tainted heparin scandal

However, an FDA spokesperson says no details were available on those “new efforts” the agency will undertake to ensure quality control, though a spokesperson with the Department of Health and Human Services, which oversees the FDA, says more information will be available when Obama releases the more detailed budget in April.

The Bush administration largely opposed the idea because of safety concerns. One cannot soon forget the toll tainted heparin took on the U.S. just last year. More than 80 people died and hundreds more were sickened when vials heparin imported from a China manufacturing plant were found to have been contaminated. FDA admitted then that it didn’t have sufficient staff to properly inspect all food and drug manufacturing plants on foreign soil.

Countries such as Canada sell medicines for much less than in the United States because the government helps control prices. Critics of importation say that buying drugs from foreign countries would leach vital funds from the U.S. drug industry that otherwise would be used to research new therapies and innovations.

In the past several months, the FDA has stepped up quality control measures by setting up offices overseas to inspect food and drugs being imported into the U.S. The first offices were placed in China.

SOURCE: Heparin Recall › New budget supports plan for importation of drugs

AM2PAT is now the subject of a criminal investigation. Federal investigators say the company was so focused on making profits that it did not conduct necessary safety tests and instead covered up the matter by falsifying reports to make it appear those tests had been conducted.

Earlier this week, workers at the plant pleaded guilty for their roles in the scandal and were sentenced to four years in prison. The company’s president, Dushyant Patel, faces numerous charges but has apparently fled to his native country India. If convicted, he faces up to 95 years in prison.

According to reports, the FDA received complaints that there were “orange specks,” or “yellow sediment” floating in the unopened syringes, or that the medicine inside appeared “muddy brown.” Despite the reports, which are recorded as early as November 2005, the FDA didn’t follow up on the complaints until 22 months later.

Food and drug manufacturing plants should be inspected by the FDA every two years, but many plants, such as AM2PAT have received site visits about every five years, according to a report from the Government Accountability Office. The report also shows that between 2002 and 2007, FDA inspectors visited only about 25 percent of the 5,616 registered plants each year.

SOURCE: Heparin Recall › FDA knew of tainted syringes two years before inspecting plant

Earlier this week two former workers at the plant, plant manager Aniruddha Patel and quality control director Ravindra Kumar Sharma, were sentenced in federal court to more than four years in prison for allowing the tainted drugs into hospitals and clinics in Colorado, Florida, Illinois and Texas. Last week, the company’s chief executive, Dushyant Patel, was indicted on 10 charges for fraud and selling adulterated medical devices. A warrant is out for his arrest.

The drugs were not produced at the plant, but were put into the syringes and shipped to the hospitals and clinics from there. According to Patel, the company recalled the syringes a year ago after federal officials began investigating the outbreak.

“Citizens in this country trust that producers of medical devices aren’t lying when they say that have adequately tested a given product,” said U.S. Attorney George Holding to the Associated Press. “As we’ve seen in this case, such lies can literally mean the difference between life and death.”

SOURCE: Heparin Recall › Two sentenced for role in tainted heparin, saline syringes

Ralph Sell of Lincoln, Nebraska, says that his wife Alice was undergoing cancer treatments in December 2007 when a syringe contaminated with Serratia marcescens, a bacteria that can cause serious injury or death, was used on her. She suffered high blood pressure, disorientation and sepsis. She died a year later at the age of 82 of “acute respiratory failure.” It has not yet been determined if the contaminated syringe may have led to her death.

Sell filed suit against Baxter International as well as its subsidiary Baxter Healthcare Corp., B. Braun Medical Inc., and AM2 PAT Inc, also known as Sierra Prefilled. A spokesperson for Baxter says the company has no role in the lawsuit, as it does not sell prefilled saline syringes. AM2 PAT did recall saline prefilled syringes in December 2007 and January 2008 because some of the syringes were tainted with the bacteria.

Baxter currently faces numerous lawsuits stemming from a 2008 recall of the blood thinner heparin. Batches of the company’s heparin manufactured in China were found to have been contaminated with over-sulfated chondroitin sulfate (OSCS). The tainted heparin is believed to have contributed to the deaths of more than 80 Americans and caused serious illnesses in hundreds more.

Sell’s lawsuit against the companies seeks unspecified damages and payment for medical costs.

SOURCE: Heparin Recall › Baxter named in contaminated saline syringe lawsuit

The new standards were proposed by scientists with U.S. Pharmacopeia, a nonprofit public health group that sets standards for the quality, purity, strength and consistency of medicines. A spokesperson with the group says the new standards are the best as scientifically possible at this time.

The revisions for testing the popular blood thinner were first requested by the FDA when the contaminant was identified in March. The changes are expected to go into effect on August 1 and include three identification tests and screening for organic impurities.

Baxter was one of the leading manufactures of heparin, producing half of the injectable heparin sold in the U.S. and generating about $30 million in sales each year. Baxter stopped sales of heparin last year and has yet to resume selling the anti-coagulant. The company is facing numerous lawsuits from families affected by the tainted heparin.

SOURCE: Heparin Recall › Scientists propose new testing standards for heparin

American Capital purchased 87 percent of Scientific Protein Laboratories in 2006. Scientific Protein Laboratories has a fair market value of $186.5 million. Last year, the parent company sought coverage from its insurers for lawsuits related to Scientific Protein Laboratories’ involvement in the tainted heparin scandal.

While Baxter International is at the center of the tainted heparin controversy, the Charter Oak Fire Insurance Co. and Travelers Property Casualty Co. of America argue that in its application for coverage, Scientific Protein Laboratories’ parent company American Capital claimed it had no subsidiaries and never mentioned Scientific Protein Laboratories or its China-based heparin venture, according to the report. In its lawsuit filed last week, the insurance companies claim that “American Capital provided false answers to Charter Oak and Travelers regarding the non-existence of subsidiaries.”

The lawsuit also claims that American Capital and Scientific Protein Laboratories entered into an agreement with Baxter International that included making payments to Baxter and giving “rights to insurance proceeds and benefits,” according to the report.

SOURCE: Heparin Recall › Heparin producer’s insurers file lawsuit

Last year the FDA announced it would place more than 60 food and drug regulators worldwide in an effort to keep unsafe drugs out of the country. Late last year the first offices opened in China, a country whose products have made headlines over the past several months for harming hundreds of thousands of people around the globe.

Aside from lead paint on toys, faulty cribs, tainted pet food and contaminated milk, China was also the site where investigators found a drug manufacturing company had contaminated batches of the blood thinner heparin with oversulfated chondroitin sulfate (OSCS). OSCS mimics the appearance of heparin but can cause adverse reactions and even death.

Before the contaminate was detected, the OSCS-laced heparin was imported into the United States, where it was administered to patients. The tainted heparin killed more than 80 people and sickened hundreds more.

The FDA reports that India is the fourth largest exporter of drugs and biologics into the U.S., according to Med Page Today.

The FDA also announced last week that it will launch a voluntary two-year “Secure Supply Chain” pilot project to help promote the safety of drugs and active drug ingredients made outside the U.S. The program is designed to assist the FDA in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements.

SOURCE: Heparin Recall › FDA opens offices in India to help oversee drug importation

Dr. Torti joined the FDA in May, just as the tainted heparin scandal was still brewing at the agency. Dr. Von Eschenbach recruited Dr. Torti to “help bolster the agency’s scientific infrastructure,” according to the news story.

Last year more than 80 Americans died and hundreds more became ill after they received injections of the blood thinner heparin. An investigation revealed that batches of heparin manufactured in China had been contaminated. The FDA later admitted it was not sufficiently staffed to inspect all foreign food and drug manufacturing plants.

Dr. Torti bypassed Dr. Janet Woodcock for the interim FDA commissioner post. Dr. Woodcock was the FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research. She had been favorite choice for the post by pharmaceutical manufacturers. Congressional critics claimed she was too closely tied to pharmaceutical groups and cited serious drug safety issues under her watch, including the tainted heparin scandal.

SOURCE: Heparin Recall › Torti named interim commissioner of FDA

The study also reported, “the use of heparin manufactured by Baxter Healthcare was the factor most strongly associated with reactions (present in 100 percent of case facilities vs. 4.3 percent of control facilities).” Those facilities included 21 dialysis facilities that reported reactions and 23 facilities that had no reported reactions. Adverse reactions reported included hypotension, nausea and shortness of breath. Most symptoms presented within 30 minutes of administering the drug.

All of the facilities that reported adverse reactions had vials of heparin manufactured by Baxter Healthcare that were contaminated with OSCS, according to the report. Researchers found that of the 130 reactions for which information on the heparin was available, more than 98 percent occurred in a facility that had OSCS-laced heparin on premises. Of the 54 reactions for which the lot number was known, the report shows that 96.3 percent occurred after the patients received the OSCS-tainted heparin.

According to the report, “Heparin contaminated with OSCS was epidemiologically linked to adverse reactions in this nationwide outbreak. The reported clinical features of many of the cases further support the conclusion that contamination of heparin with OSCS was the cause of the outbreak.”

SOURCE: Heparin Recall › CDC study provides details on OSCS-laced heparin

The program is designed to assist the FDA in its efforts to “prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and may not be compliant,” according to the FDA press release.

“This initiative creates incentives for drug makers to develop and maintain secure supply chains,” said Deborah Autor, Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in the press release. “This is one of several agency initiatives to enhance drug product safety.”

The pilot program compliments the agency’s recent placement of offices in foreign countries to oversee quality control standards of foods and drugs imported into the U.S. The efforts likely stem from scrutiny the agency received last year after batches of heparin produced in China were found to have been contaminated. The tainted heparin killed more than 80 people and sickened hundreds more before an investigation revealed that the heparin was most likely contaminated during manufacturing at Baxter International’s China plant. The finding led to an FDA recall of specific lots of heparin.

In the months following the heparin scandal, the FDA has come under fire from lawmakers and advocacy groups for not adequately inspecting foreign food and drug manufacturing plants, and for mishandling the contaminated heparin investigation.

SOURCE: Heparin Recall › FDA launches pilot project to oversee foreign drug products

The Quaids also sued Baxter Healthcare Corp. over the packaging and labeling of its high-dose and low-dose heparins, arguing the two bottles are easily confused. Other cases of heparin overdose have been reported and linked in part to the confusing packaging. The Quaid’s lawsuit against Baxter was dismissed on jurisdictional grounds because the event occurred in California.

Baxter was no stranger to the spotlight in 2008, facing numerous lawsuits most notably for the tainted heparin scandal earlier in the year. More than 80 Americans died and hundreds more were sickened after receiving doses of heparin made at Baxter China plant. An investigation found that lots made in that plant were contaminated with over-sulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death. The FDA issued a recall on batches of Baxter’s heparin.

According to news reports, the Quaid-Cedars-Siani case indicates that Baxter may also sue Cedars-Siani for improperly administering the blood thinner to several patients at the hospital, including the Quaid’s newborn twins.

SOURCE: Heparin Recall › Quaid-Cedars-Siani lawsuit over heparin overdose finally closed

Joyce Ann Osteen filed the suit in St. Clair County, Illinois, and claims Baxer purposefully added a contaminant, over-sulfated chondroitin sulfate, or OSCS, to heparin manufactured in its China plant. The tainted heparin was distributed to the U.S., where hundreds of allergic reactions occurred. More than 80 people died and hundreds more were sickened by the tainted heparin before an investigation led to a recall of batches of heparin manufactured at Baxter’s China facility. The FDA later issued an announcement saying that the contaminant was an inexpensive and unapproved ingredient that mimics heparin.

OSCS costs only $9 to produce compared to $900 for heparin, the suit contends.

“The recalled heparin was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses,” the suit states. “Baxter placed tens of thousands of patients, including the Plaintiff at unnecessarily risk of serious injury and/or death.”

The suit states Osteen and the class members who purchased the heparin “suffered actual damages as a proximate result of Baxter Healthcare Corp.’s deception in that they were deprived of the benefit of their bargain.” According to the complaint, Osteen is asking the court to certify the complaint as class action. She also is seeking damages of less than $74,999 per plaintiff or class member.

SOURCE: Heparin Recall › Class action lawsuit filed against heparin manufacturer Baxter

Early in 2008, more than 80 Americans died and hundreds more were sickened after receiving injections of heparin. An investigation found that batches of heparin manufactured in Baxter International’s China facility had been tainted with a contaminant that caused severe allergic reactions in patients who received the doses. As a result, lots of heparin manufactured by Baxter International were recalled.

The Chicago Tribune story says both the FDA and Baxter International believe the heparin was “intentionally adulterated by suppliers in China.”

The tainted heparin scandal beat out other big local news stories in the Chicago Tribune’s top 10 list, including the Tribune Co.’s filing for Chapter 11 bankruptcy protection; the city reaching the final phase of competition to host the 2016 Summer Olympics; and the selling of Wm. Wrigley Jr. Co. to Mars Inc., creating the world’s largest confectionary company.

The concern over imported foods and drugs landed heparin on U.S. News & World Report’s list of top health stories. Titled, “Dubious Drugs, Tainted Foods Top 2008’s Health Stories,” the story groups the tainted heparin with salmonella-tainted jalapeno peppers imported from Mexico on its list of food and drug scares. Contaminated heparin keeps company on that list with with the FDA’s warning about over-the-counter cold meds for young children and the American Cancer Society’s announcement that for the first time since 1998, when statistics began to be compiled, the number of people who developed cancer or died from the disease has dropped.

Here’s to a happier, healthier New Year!

SOURCE: Heparin Recall › Heparin scandal makes 2008 top 10 lists

Allie recently posted a video on YouTube in light of the heparin scandal, asking “Is my insulin tainted?” Last year, more than 80 Americans died and hundreds more were sickened after receiving doses of the blood thinner heparin. An investigation found that batches of heparin manufactured at Baxter International’s China facility had been contaminated. That led to a recall, and further questions about the quality of the foods and drugs imported into the United States from foreign countries, especially China.

Demanding answers, Allie made phone calls to insulin companies and 24 hours later, reported on her results. Her first call was to Sanofi Aventis, a pharmaceutical company based in Bridgewater, NJ. Sanofi Aventis manufactures medications such as Allegra, Ambien, and Ketek as well as diabetes medications such as insulin glargine injection Lantus and insulin gluisine injection Apidra. Allie reports that she was able to speak with a customer service representative with Sanofi Aventis who informed her that the raw materials are manufactured in Germany and are “completely FDA approved and do not come from China.”

Allie compared her attempts to reach Eli Lilly and Company’s customer service as being in the “twilight zone.” Her repeated calls “during normal business hours” were either cut off or unanswered. Lilly is the 10th largest pharmaceutical company in the world and offers a variety of products. It’s diabetes products include Byetta, Gluagon and Humulin.

Allie then called Novo Nordisk, a manufacturer and marketer of pharmaceutical products and services headquartered in Denmark. Novo Nordisk offers a line of diabetes products such as insulin pens, needles and hypokits. She was told that its diabetes products are bottled in North Carolina.  Its FlexPen is manufactured in Denmark. Customer Service assured her they follow FDA guidelines and run batch tests to ensure safety.

SOURCE: Heparin Recall › Diabetic questions safety of insulin in light of heparin scandal

According to the report, the Institute of Medicine issued a statement recommending the USDA’s Food Safety and Inspection Service and the food safety activities of the FDA within HHS should be unified. The consumer groups argue that combining the two agencies would cause the dysfunctional FDA program to undermine the good work of the USDA. Thus, the groups are recommending reforming the food inspection process.

The FDA is a hot topic for the Obama administration. The agency has come under fire in recent months for its handling of contaminated foods and tainted imports. Last spring, the agency incorrectly identified the source of a salmonella outbreak to tomatoes before concluding that jalapeno peppers from Mexico were the cause.

And, earlier this month, Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee questioned the FDA’s handling of the contaminated heparin scandal that caused more than 80 Americans to die and hundreds more to fall ill. The heparin was found to have been contaminated at a China manufacturing plant. After issuing a recall on the tainted heparin, the FDA admitted it did not have the staff to fully inspect all foreign food and drug manufacturing plants to ensure quality and safety of drugs imported into the United States.

SOURCE: Heparin Recall › Consumer groups, institute team up to urge FDA reform

The news is a double-blow for Europeans, not only for the 43 employees who lost their jobs, but for consumers who have expressed concerns about the quality of drugs and other products made and manufactured in China.

Products made in China have been continuously under fire for the past several months, from milk tainted with melamine to toys covered with toxic lead paint. Earlier this year lots of the blood thinner heparin manufactured in China were recalled after more than 80 Americans died and hundreds more fell ill after receiving doses of heparin. Select batches of heparin were found to have been contaminated during production at Baxter International’s China plant.

Since then, the FDA has announced plans to better track imports of food and drugs. One of its first steps was to open three offices in China to oversee quality control standards of products imported to the United States. Another 50-plus offices will be opened worldwide, though the agency says it could take years to effectively inspect all foreign facilities.

According to Bloomberg, China has more than 700 plants registered to ship drugs to the United States – more than any other country.

SOURCE: Heparin Recall › Europeans now dependent on China for Panadol, Tylenol

Last year, heparin was thrust into the spotlight after more than 80 patients who had received the blood thinner died and hundreds more became ill. An investigation to the adverse reactions found that batches of heparin manufactured in Baxter International’s China plant were contaminated with over-sulfated chondroitin sulfate (OSCS). That discovery spurred the FDA to recall lots of heparin made by Baxter International.

“Perhaps the most surprising fact that emerged in our three months of reporting on contaminated heparin ingredients from China: The U.S. government has little ability to know whether the drugs we are taking are safe or not,” Eisner points out.

Last month, the FDA vowed to step up its efforts to oversee quality control of imported foods and drugs by opening offices in foreign countries. Its first offices opened in China. The FDA plans to place more than 60 food and drug regulators worldwide over the next several months. However, the agency says it will take more than a decade to adequately inspect all foreign drug manufacturing plants.

“As a result,” Eisner writes, “doctors must take it on faith that the medicines they are prescribing are exactly what they are supposed to be.”

SOURCE: Heparin Recall › Tainted heparin may have caused death of infant

Heparin is generally used when a patient – adult or infant – receives fluids through a central line to prevent a blood clot from forming, which could eventually grow and break off and kill a patient. But if the blood is too thin, it puts the patient at risk for life-threatning bleeding or hemorrhages, including in the brain.

The Quaids also sued Baxter Healthcare Corp. over the packaging and labeling of its high-dose and low-dose heparins, arguing the two bottles are easily confused. Other cases of heparin overdose have been reported and linked in part to the confusing packaging. The Quaid’s lawsuit against Baxter was dismissed, according the Associated Press.

Baxter International has faced numerous lawsuits lately, most notably for the tainted heparin scandal earlier this year. More than 80 Americans died and hundreds more were sickened after receiving doses of heparin made at Baxter International’s China plant. An investigation found that lots made in that plant were contaminated with over-sulfated chondroitin sulfate (OSCS). The contaminant can cause serious allergic reactions and even death. The FDA issued a recall on batches of Baxter’s International’s heparin.

The Associated Press reports that the petition filed Monday in the Quaid-Cedars-Sinai case indicates that Baxter International may also sue Cedars-Sinai for improperly administering the blood thinner to several patients at the hospital, including the Quaid’s newborn twins.

SOURCE: Heparin Recall › Quaids get settlement in heparin overdose case

Franke Leon Isom of Webster, Ken., died Dec. 14, 2007, a day after he was given heparin during treatment at Woodland Dialysis Clinic in Elizabethtown. Attorneys argue that Isom received part of the 55,000 gallons of heparin that was contaminated with over-sulfated chondroitin sulfate (OSCS).

Earlier this year, a series of deaths and adverse allergic reactions from patients who had received doses of heparin led to an investigation that linked the reactions to lots of heparin made at Baxter International’s China plant. Further review found the heparin had been contaminated with OSCS during manufacturing in China. Shortly thereafter, the FDA ordered a recall. The tainted heparin is blamed for more than 240 deaths worldwide and caused hundreds more people to fall ill from allergic reactions to OSCS, such as hypotension.

The lawsuit, filed on the behalf of Isom’s estate, is one of 50 similar civil tort claims against Scientific Protein Laboratories and Baxter International, according to the news report. Attorneys argue that recalled lots of heparin were still found on hospital shelves months after the recall went into effect.

SOURCE: Heparin Recall › Another lawsuit filed in tainted heparin scandal

Heparin from another company, APP Pharmaceuticals Inc., wasn’t considered a problem, though in a letter to Congress in October, the FDA said one patient taking the APP heparin had a severe reaction that may have led to his death, according to the news report. APP responded in a letter to the congressman’s staff that the company had thoroughly reviewed the case and did not believe the patient’s death was a result of contaminated heparin.

Rep. Barton wants to know why the FDA has “no information” about whether that patient’s death was caused by the same contaminant – over-sulfated chondroitin sulfate – as was found in Baxter International heparin.

Rep. Barton has been on the FDA’s case for more than a month, questioning the agency’s handling of the heparin recall, claiming it misrepresented deaths tied to the product , arguing that it didn’t thoroughly investigate the matter, and ordering answers on why the agency took six months to seize lots of contaminated heparin from an Ohio agency.

SOURCE: Heparin Recall › Barton wants answers from FDA about heparin scandal

Von Eschenbach was appointed by President Bush in 2005 after the agency’s previous commissioner resigned due to ethical issues, the AP reports. While under von Eschenbach’s helm, the FDA has undergone scrutiny by Congress and consumer groups over issues such as the tainted heparin scandal earlier this year.

The FDA ordered a recall on batches of the blood thinner heparin made at Baxter International’s Chinese facility after some lots were found to have been contaminated with over-sulfated chondroitin sulfate. The tainted heparin killed more than 80 Americans and sickened hundreds more before the contaminant was identified and linked to the China plant.

Over the past several months the FDA continued to come under fire for its handling of the heparin recall. Last week, Rep. Joe Barton, a ranking member of the House Energy and Commerce Committee, questioned why the FDA waited six months to seize lots of contaminated heparin from Celsus Laboratories in Ohio. Last month Rep. Barton also asked the Government Accountability Office to look into the agency’s overall handling of the recall.

Despite the criticism, von Eschenbach has been favorably regarded for strengthening the agency’s international food and drug regulations, opening three offices in China last month and vowing to place more than 60 food and drug regulators worldwide to oversee quality standards of food and drugs imported to the United States.

President-elect Obama is considering a list of candidates to succeed von Eschenbach that includes Baltimore’s health commissioner, several prominent physicians, and former and current FDA officials, according to AP.

SOURCE: Heparin Recall › FDA commissioner announces plans to resign next month

The Web site details the safety measures the pharmaceutical company has taken over the past several months, including enhanced labeling, unit-of-use bar codes, large lettering and color-coded bottle stoppers to help eliminate misuse of its products, which also includes injectible drugs for oncology.

APP Pharmaceuticals became the only U.S. provider of the blood thinner heparin after batches of heparin manufactured at Baxter International’s Chinese plant were found to have been contaminated. The tainted heparin killed more than 80 Americans and sickened hundreds more before the FDA pinpointed the source of contamination and issued a recall of the specific lots.

APP Pharmaceuticals has two U.S. manufacturing plants and one in Puerto Rico, however it imports its raw material from a Chinese supplier.

Heparin also was thrust into the spotlight in 2007 with the much-publicized overdosing of actor Dennis Quaid’s newborn twins. The newborns nearly died after they were accidentally given 1,000 times the intended dose. Other cases of heparin overdose have been reported and linked in part to similar packaging of high-dose and low-dose heparin.

APP Pharmaceuticals‘ safety initiative comes on the heels of new federal requirements for health care facilities that go into effect January 1, requiring health care facilities to have in place a comprehensive anticoagulation management plan in order to be accredited by the U.S. Joint Commission.

SOURCE: Heparin Recall › Drug company launches Web site to highlight safety measures

If so, Dashle will inherit a department that oversees the FDA, an agency that is rife with issues. The agency has been the subject of criticism over its handling of the tainted heparin scandal earlier this year in which more than 80 Americans were killed and hundreds more sickened after receiving injections of heparin from China.

The FDA, struggling with low staff levels, is gradually hiring more employees. It recently began placing food and drug inspectors and opening foreign offices – the first of which was in Beijing, China – in an attempt to oversee quality control of food and drugs imported into the U.S. However, hiring enough staffers to fully inspect those foreign manufacturing plants could take years.

“The people who have been doing the hiring say it will take three years to get those folks up and running and fully trained to carry out any work,” said Marcia Crosse, GAO’s director of health care, in the Federal Times story. “They’ve had to shift away from the traditional model of having other countries oversee their own pharmaceuticals. Where we may have trusted Germany to oversee its companies, the same can’t be said for China and India.”

The National Treasury Employees Union president says she is hopeful that the Obama administration will make hiring more inspectors, scientists and chemists for the agency a priority.

SOURCE: Heparin Recall › Daschle likely to inherit agency rife with issues

First, researchers noted that the evaluations were short term and that many of the studies were supported by the generic drug companies, who have a vested interest in the positive outcome of the results.

Furthermore, the story points out that generics are more likely to be made in factories in other countries where labor and overhead are far less expensive, such as India and China. In fact, China is producing more and more generic drugs and, according to the story, is expected to offer even lower prices in the future.

This should raise concerns with the general public, given the tainted heparin scandal earlier this year that killed more than 80 Americans and sickened hundreds more. That tainted heparin was traced to manufacturing plants in China and resulted in a major recall of the blood thinner.

The FDA is hoping to give more guidance on U.S. quality control standards on imported food and drugs by opening offices and placing regulators in foreign countries. The first office opened in Beijing last month. However, congressional investigators say that inspecting the more than 3,000 drug plants in other countries could take more than a decade.

SOURCE: Heparin Recall › Generics may be bio-equivalent of brands, but are they as safe?

Baxter International makes heparin, the blood thinner that is routinely used before treatment for kidney dialysis to prevent blood clots as well as during many surgeries. Several lots of heparin manufactured in Baxter International’s China plant were recalled by the FDA earlier this year after they were found to have been contaminated during manufacturing. The tainted heparin ultimately killed more than 80 Americans and sickened hundreds more before an investigation led them to Baxter International’s China plant.

The company also lobbied on bills to improve the safety of drugs imported from foreign countries, and stood up against an effort in Congress to reform the U.S. patent system. According to the story, high-tech companies support that bill, claiming that it would cut down on “frivolous patent-infringement lawsuits.” Baxter International and the pharmaceutical industry argued that doing so would weaken patent protections on drugs by reducing infringement penalties. The bill passed the House but is not expected to pass the Senate this year.

Baxter International also lobbied to give the FDA authority to approve generic versions of biotech drugs, which have never faced generic competition because the FDA does not have the authority to approve the less expensive versions.

SOURCE: Heparin Recall › Baxter International spent thousands on lobbying efforts

Batches of heparin were recalled by the FDA earlier this year after lots manufactured in China were found to have been contaminated with over-sulfated chondroitin sulfate. The investigation and subsequent recall followed reports of more than 80 deaths and thousands more illnesses of patients who had received doses of heparin from the lots in question.

Rep. Joe Barton, R-Texas, last week pointed out that the FDA made conflicting statements to the public and Congress about the number of deaths caused by the blood thinner. Last May, the FDA said it completed a review of three deaths linked to the tainted heparin. Last month, the FDA told Congress that only two deaths were possibly linked to the incident and the third was “unassessable.”

Baxter International, the company involved in the tainted heparin incident, conducted its own investigation and determined that the contaminant was likely not the cause of death in any of the three cases mentioned by the FDA. Baxter’s investigators reviewed patient medical records, interviewed pharmacists and nurses, and visited a hospital where one of the patients had gone before dying.

The FDA came under fire over the tainted heparin scandal after admitting it did not properly inspect Baxter’s China facility. Inspecting all foreign drug manufacturing facilities could take as long as 13 years, the agency has reported. This week the FDA opened its first foreign office, located in Beijing, China, as part of a push to place more than 60 food and drug regulators worldwide to provide guidance on U.S. food and drug quality standards.

SOURCE: Heparin Recall › Lawmaker questions FDA investigation of heparin scandal

The report revealed that inspecting the more than 3,000 overseas drug plants would take the FDA more than 13 years to complete The agency fired back, saying “The conclusion that FDA should endeavor to conduct foreign inspections based on the same criteria as domestic inspections is…problematic because of the differences in regulatory methodology and resources,” according to the Associated Press.

The need for careful inspections of foreign drug manufacturing plants has come to the forefront since the tainted heparin scare earlier this year that killed more than 80 people and sickened hundreds more. Those batches of heparin were found to have been contaminated in Baxter International’s Chinese manufacturing plant.

Now the Natural News is reporting that the FDA is refusing to release information on which Chinese companies supplied the tainted heparin. According to Natural News, the FDA claims that a confidentially agreements with producers of heparin are preventing the government agency from revealing which Chinese companies supplied heparin ingredients to the United States. It also claims that because of the Memorandum of Agreement that regulates relationships between the FDA and China, the FDA does not have the legal authority to prevent Chinese-manufactured medicines from being imported into the U.S. The FDA says it relies on companies to voluntarily rest their own heparin ingredients, a process that obviously failed last year when contaminated heparin entered the United States.

Meanwhile, Chinese health officials say that it has not been proven that the heparin was contaminated in Chinese plants, and that contamination could just have easily happened in Baxter’s New Jersey plant.

SOURCE: Heparin Recall › FDA will not name Chinese plants that supplied tainted heparin

Baxter International is the world’s largest maker of blood-disease treatments. The company also sells the blood thinner heparin, which last year was recalled after batches of the drug made in the company’s Chinese plant were found to have been contaminated. As a result, more than more than 80 people died and hundreds more were made ill after receiving the tainted heparin. At that time, Baxter was the largest heparin manufacturer, with $30 million in sales.

Most of the heparin sold in the U.S. is manufactured with ingredients made in China. China is the leading supplier of the drug largely because heparin is made from pig intestines and China has a much larger pig population, according to Natural News.

At least 12 lawsuits have been filed against Baxter by patients and family members of those who suffered ill effects of the tainted heparin. As yet, Baxter has not incurred any serious legal costs from the tainted heparin crisis, Natural News reports.

In its third-quarter report, Baxter International announced that its net income increased from $395 million to $472 million, or from 61 cents a share to 74 cents a share. Much of its profit increase is attributed to international sales of products that treat hemophilia and immune disorders.

The company is predicting continued sales growth of about 5 to 6 percent, and expects cash flow from operations to exceed $2.6 billion.

SOURCE: Heparin Recall › Despite recall, Baxter International enjoys third-quarter gains

“We are sending a very clear message to producers: if you want to have access to our market you need to make products that meet our standards of quality,” Health and Human Services Secretary Michael Leavitt was quoted in the story. Leavitt oversees the FDA and other federal health agencies.

While particular attention will be paid to India, Latin America and the Middle East, the FDA will make China a priority, establishing its first office in Beijing by the end of the year. The Beijing office will employ eight U.S. staffers. Additional outposts are planned for Shanghai and Guangzhou.

Products made in China have caused much heartache lately. Last spring, the FDA
recalled batches of heparin after some lots were found to have been contaminated while produced in Baxter International’s Chinese factory. The tainted heparin killed more than 80 people and sickened hundreds more.

Similarly, dozens more products made in China have been recalled over the past several months for harming people, including tainted baby formula, toys made with lead-based paint, and contaminated pet food.

Details on how the FDA will carry out the plan are unclear, as FDA officials admit that the hiring of several dozen more staffers, as the plan lays out, would not provide enough personnel to visit the thousands of plants around the world.

SOURCE: Heparin Recall › FDA to set up offices worldwide

Last month I told you that California Rep. Harry Waxman, who serves as head of the House Oversight and Government Reform Committee, raised concerns that items outlined on the FDA’s 2007 priorities list appeared to prioritize industry desires over consumer protection.

This, just months after more than 80 American deaths were linked to tainted heparin that was made in Baxter International Inc.’s facility in China. FDA officials later acknowledged they had not inspected that facility and claimed they had insufficient staff and financial resources to regularly inspect overseas manufacturers.

Today, the Washington Post reported that the FDA has hired a public relations company it improve its image. However, in yet another PR blunder, the story reports that the way it hired the company may also be raising eyebrows.

The story suggests that the FDA may have violated government contracting rules by not holding a bidding competition for a $300,000 contract hiring a firm to create “a lasting positive public image for the agency.” Instead it made a deal with Alaska Newspapers Inc., (ANI) which is exempt from having to compete for federal work because it qualifies for special set-asides. ANI agreed to funnel all the work to the FDA’s agency of choice, Qorvis Communications. Apparently the FDA’s new PR head, Mildred Cooper, had connections to the firm and wanted to use it.

The FDA cancelled its contract with ANI/Qorvis Communications after the Washington Post’s story ran. And while the FDA claims it never meant to do anything questionable during the selection process, this latest blunder certainly hasn’t helped the organization’s public image.

SOURCE: Heparin Recall › FDA makes blunder during hiring of PR firm to improve image

Linhardt was among the researchers who discovered the source of tainted heparin that was responsible for at least 149 deaths since the beginning of 2007. Manufacturer Baxter International, which supplies about half of the heparin used in the U.S., recalled its supplies of heparin made in China after more than 80 patients suffered serious allergic reactions and death following its use.

According to a report by Bloomberg News Service, Chinese pig farms that provide source material for heparin are not monitored by the U.S. Food & Drug Administration, which increases the risk for contamination. Continued use of traditional heparin products manufactured in these facilities leaves the door open for another contamination event, Linhardt says in the Bloomberg report.

In addition to Baxter’s product, a smaller scale contamination problem was reported with the Lovenox heparin medicine manufactured by Sanofi-Aventis, according to a report by Reuters.

Linhardt presented his team’s synthetic heparin results at the recent American Chemical Society meeting, according to Reuters, where he told those in attendance that today’s heparin manufacturing methods are “simply unsafe.”

Scientists are working on creating larger quantities of the synthetic heparin, which Linhardt hopes will reach human clinical trials in five years, Reuters reports.

SOURCE: Heparin Recall › synthetic heparin in development