Even on the campaign trail, Obama’s camp said it would support the plan but that there would have to be measures in place to ensure the FDA was properly inspecting the plants where drugs are being manufactured.

After all, it was just one year ago that hundreds of people became ill and more than 80 died after receiving injections of the blood thinner heparin that was later found to have been contaminated at pharmaceutical giant Baxter International’s manufacturing plant in China.

The FDA later admitted that it simply didn’t have the manpower to inspect all foreign food and drug manufacturing plants and thus couldn’t ensure the safety of those products. Late last year, the agency began placing food and drug inspectors to oversee the safety of foods and drugs imported into the U.S. The first three offices were opened in China.

Allowing Americans to purchase their drugs from foreign countries can provide a tremendous savings to consumers, but some lawmakers say that it is too risky a gamble. At a hearing of the Senate Finance Committee, Kansas Republican Pat Roberts asked the White House if it was in favor of first establishing some controls before moving forward with the importation plans. “Would you also agree that, if such a proposal were to move forward, we should demand that any drug imported into the U.S. meet the same high safety and efficacy standards of our FDA including bioequivalency standards?” he asked.

White House budget director Peter Orszag answered by simply saying, “Yes.”

SOURCE: Heparin Recall › Lawmakers debate safety of importing drugs

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

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

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

According to the report, aides for both candidates said that recent health scares had dampened their candidates’ enthusiasm of reimportation. Neither candidate has abandoned the prospect; however, they admit it has become a more controversial subject.

Other countries, such as Canada, have government price controls that keep prescription drug costs down, making reimportation of foreign drugs a far more attractive option, especially for those who spend hundreds and thousands of dollars on prescriptions each year. While several U.S. bills on reimportation have been proposed, none have become law, the report stated.

Organizations representing pharmaceutical companies such as the Generic Pharmaceutical Association (GPhA), oppose the practice, arguing that there is no guarantee drugs or goods from other countries would be safe, Reuters/Boston Globe reported.

Earlier this year, American deaths were linked to tainted heparin that was made in Baxter International Inc.’s facility in China. According to news report, FDA officials acknowledged they had not inspected that facility and claimed they had insufficient staff and financial resources to regularly inspect overseas manufacturers.

SOURCE: Heparin Recall › Candidates review reimportation of prescription drugs