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

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

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

Earlier this year, the FDA recalled lots of heparin manufactured in a Baxter International Chinese plant after batches were found to have been contaminated with over-sulfated chondroitin sulfate. The FDA recall was the result of an investigation into the deaths of more than 80 people and illnesses of hundreds more people after receiving doses of heparin.

CNN Money reports that the recall process is voluntary. Companies are not required to immediately comply with the FDA’s request, however FDA inspectors reportedly told Celsus Laboratories in April that its recall efforts were insufficient, and a month later followed up in a letter to the company expressing the same concerns. Last month, the FDA seized 11 contaminated lots of heparin from Celsus Laboratories.

The FDA won’t elaborate on why Celsus Laboratories’ efforts were less than satisfactory, saying its investigation into the matter is still ongoing. The agency did say that on occasion it sends safety officers to companies to conduct “100 percent effectiveness checks” to ensure they are taking proper measures to destroy the recalled products.

Rep. Joe Barton, a member of the House Energy and Commerce Committee, has been following the heparin situation and, last month, asked the Government Accountability Office to look into the matter. The congressman also wrote a letter to the FDA commissioner saying he wants to know when the agency first decided it was appropriate to seize heparin from Celsus Laboratories. He also asked for a list of all individuals involved in the decision to seize the heparin.

SOURCE: Heparin Recall › Congressman questions FDA’s slow action on heparin seizure

The U.S. Food and Drug Administration (FDA) recently announced that it will place more than 60 food and drug regulators worldwide over the next year to inspect foreign drug manufacturing plants.

However, congressional investigators say inspecting the more than 3,000 drug plants in other countries could take as long as 13 years, according to the Associated Press. In comparison, U.S. pharmaceutical factories are inspected by the federal government every 2.7 years on average.

Of the 3,249 foreign facilities for which the FDA has set enforcement priorities, the government agency has only been able to inspect an average of 247 per year, compared to 50 percent of the 3,000 U.S. facilities, according to the Government Accountability Office (GAO).

Inspections of most domestic plants involve ongoing surveillance of facilities’ manufacturing practices. By contrast, foreign facilities are inspected before they are allowed to ship drugs to the U.S. When problems are found at a foreign plant, steps are taken to fix them. However, follow up inspections on those measures by the FDA can take up to five years, the report said.

The GAO report stated significant growth in the foreign drug manufacturing market has presented the FDA with “significant challenges” in ensuring the safety of imported drugs, and urged more surveillance of all foreign drug facilities.

SOURCE: Heparin Recall › FDA inspections of foreign drug facilities could take years