In response to the findings, in September 2008, the FDA suspended importation of more than 30 different generic drugs produced at the two Ranbaxy facilities. The list included widely prescribed antibiotics, diabetes drugs and allergy medicines.
Ranbaxy officials declined to be interviewed about the ongoing investigation into its alleged manufacturing practices, but in a written statement the company said it has responded to the FDA and will continue to cooperate with the agency.
Drug and medical-device safety experts acknowledge that even with proper funding and adequate resources, the FDA will continue to be challenged by medical-products exports that fall short of the agencys standardseither through innocent mistakes or unscrupulous cost-cutting tactics. The question, says Linda Bentley, a lawyer and FDA specialist with the law firm Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, is whether the FDA can work with drug companies like Ranbaxy as well as devicemakers to identify problems earlier in the supply chain and prevent large-scale contamination and safety problems.
Such an effort will involve requiring companies to validate every step of sourcing, manufacturing and shipping activity within drug companies and devicemakers supply-chains, Bentley says. Exercising such tight controls, however, can be a significant challenge since companies often outsource various aspects of their product production.
Ive worked on manufacturing agreements, and its easy to write in periodic inspections of plants you contract with, but it often isnt as easy to make sure that it happens as scheduled, or that its properly inspected to catch any problems, Bentley says.
A recently announced pilot program could help the FDA find some answers for better policing the supply chain and helping inspectors focus on potential safety problems. The program, called the Secure Supply Chain Pilot, is still in the comments stage and is not expected to begin before 2010. Once launched, however, the pilot would enroll 100 drugmakers to test a verification process that could expedite importation of drugs that meet specific criteria, says Huascar Batista, an import/export team leader with the FDAs division of new drugs and labeling compliance.
What will happen is that the applications will be reviewed to make sure that the supply-chain processes companies certify meet our criteria, and that were comfortable that the drugs can go through customs without an inspection, Batista says. These are going to be for products that the FDA has already inspected and that have met our requirements.
Approval for participation in the two-year pilot would be drug-specific, not company specific, FDA officials say. And each drug will have to follow the exact production and shipping route that has been approved and certified through the program in order to be expedited through customs. Right now, that can vary, Batista says. The products can come from different points as long as they come from the correct manufacturer.
If the pilot is successful in helping to guarantee the safety of large numbers of imported drugs, FDA inspectors will be free to zero in on drugs that have the potential to harm consumers, says Joseph Famulare, deputy director in the compliance office in the FDAs Center for Drug Evaluation and Research. This program gives us time to focus our resources on products that are more problematic, Famulare says. It incentivizes companies not to lose that privilege so their products can be expedited through customs.
Rick Chambers, a spokesman for drugmaker Pfizer, which earlier this month announced it has partnered with India-based drugmaker Aurobindo Pharma to import generics into the U.S. and Europe, says his company supports the FDAs pilot program, and believes it could be a good weapon among the agencys still-developing arsenal of solutions for ensuring the safety of imported drugs and medical devices.
The idea would be to have companies secure and verify their entire supply chain, and that would certainly be more effective and cost-efficient, Chambers says. Our desire, however, would be a program that looks at a companys entire supply-chain process and not just product by product.
But while various plans are in the works to beef up import-safety controls, observers say the ultimate direction depends on how much emphasis the agencys pending new leader, Margaret Hamburg, places on tackling these concerns.
There is no FDA commissioner yet, Bentley says, and it will take a while for the nominee to go through the vetting process and, if approved, figure out whats going on there.