Bush AIDS Drug Program Cuts Ranbaxy Drugs
1 CommentBy Ed Silverman // September 25th, 2008 // 4:55 pm
Talk about a delayed reaction. Two months ago, news broke that federal prosecutors alleged Ranbaxy Labs falsified records resulting in the production and sale of meds that didn’t meet FDA standards. The allegations under investigation include fabricating bioequivalence and stability data to support AIDS drugs to be paid for by the Pepfar and distributed to foreign countries (back story).
Then last week, the FDA got around to authorizing authorities to halt imports of 30 Ranbaxy meds (look here), but only after the House Energy & Commerce committee began probing the extent to which the agency was monitoring the problems with Ranbaxy plants in India (more back story).
Among the drugs allegedly imperiled by Ranbaxy’s shenanigans are AIDS meds that are paid for by the President’s Emergency Plan for AIDS Relief, or PEPFAR, which buys meds for African countries and other developing countries, doled out nearly $9 million to Ranbaxy for its generics. However, PEPFAR officials have seemed oblivious to the scandal. “It’s pretty clear that the system is working well, and it protects African families just like American families are protected,” Ambassador Mark Dybul, the US global AIDS coordinator, reportedly said days after the news broke (look at this).
Now, PEPFAR officials have suspended funding for three Ranbaxy generics until the FDA verifies that manufacturing issues in one of the plants in India are rectified, Bloomberg News reports. Of course, they took action only after the House Energy & Commerce Committee widened its Ranbaxy probe to write a letter last week to US Secretary of State Condoleeza Rise about the extent to which PEPFAR officials were aware of the problems and any actions taken.
“Funds cannot be used to support new orders” for the three Ranbaxy drugs - zidovudine, lamivudine and nevirapine - manufactured at one of the plants in India, according to an e-mail the news service received from the AIDS program’s spokeswoman. She provided the information on the condition that her name not be used, citing policies of the State Department, which runs the initiative.
Although the FDA import ban applies only to the US market, the government decided to suspend funding for the AIDS drugs supplied overseas. It is a “principle” of the president’s AIDS initiative to “meet standards equal to those established for patients in the United States,” the PEPFAR spokeswoman tells Bloomberg.
Chuck Caprariello, a Ranbaxy spokesman, tells Bloomberg he doesn’t have firsthand knowledge of the government’s decision and couldn’t comment. All he would say is that Ranbaxy is working with the U.S. government “to resolve all of the issues and concerns that have been raised.”
There is no evidence that Ranbaxy’s medicines are harmful, though the violations could lead to defective products, according to the FDA, although some experts say a product recall should be undertaken (see our reader poll, too).
The FDA import ban, by the way, is not related to the ongoing US criminal investigation examining whether the company fabricated data to get its medicines cleared for sale.
Anne PME
Ed-
Thank you for continuing to report these important safety issues.
It is heartening to see that both republicans and democrats are joining forces to help and protect this vulnerable patient population; however, we are concerned that these latest developments may disrupt PEPFAR recipients’ access to safe versions of these vital medications.
The World Health Organization (WHO) has reported that infectious disease - HIV/AIDS, malaria, tuberculosis and hepatitis - is the world’s number one cause of death. Infectious disease does not discriminate between rich or poor. Pathogens can and often do mutate faster than we can develop and approve new and effective treatments. While it is important that all medications adhere to safety standards, it is imperative to ensure that antimicrobial medications meet all quality standards because it may extend the efficacy of existing treatments.
USFDA standards have often been referred to as ‘the gold standard’. Given the magnitude and the potential consequences of adulterated (also referred to as substandard) antimicrobials, PME would like to see any new pharmaceutical manufacturer for these and all other PEPFAR medications verified as compliant with all USFDA standards before any contract is signed or payment is made. We’d also like to see a written agreement in place requiring all PEPFAR suppliers to adhere to USFDA standards during the life of the contract, and a realistic budget and resources made available for the oversight and enforcement of all standards and terms.
The comments in the Bloomberg article do not indicate whether or not PEPFAR recipients of these Ranbaxy drugs will receive replacement product of existing supplies if they request them, or who will pay for them. Will the PEPFAR patients who received and may continue to receive these Ranbaxy drugs require additional medical monitoring, testing and/or treatment, and will these medical decisions be made by treating providers and their patients?
I hope and know that other Pharmalot followers join me in thanking all those who work to ensure access to safe prescriptions.
Anne Patenaude
Prevent Medical Error
http://www.PreventMedicalError.org