Are protections in place to prevent bribing of FDA officials?
With drugs such as Lipitor achieving lifetime sales well over $100 billion, the motivation to use any means available to ensure drug approval is clear.
Bribery of FDA officials has occurred in the past, but is unlikely to occur again for the reasons described below.
The Drug Approval Process
The overall objective of the drug approval process is to demonstrate the safety and efficacy of a drug. This process takes many years, and involves a large number of people working for many different institutions.
The FDA’s drug approval process is well documented, and is summarized here:
- Following basic research which identifies a drug candidate, an Investigational New Drug application is submitted to the FDA to seek permission to start human clinical trials
- Human clinical trials often involve thousands of individuals in dozens of institutions, under controlled conditions
- Post-approval clinical study obligations are established
- Manufacturing facilities are also inspected for complicance with best practices and for consistency of product
- The drug developer submits a New Drug Application, and FDA reviewers and independent advisors assess the clinical trial design and the drug’s safety and efficacy
Branded drugs: Too many people to bribe and too much transparency
One hypothetical way to drive an undeserving drug’s approval would be to bribe the FDA reviewers.
There are two serious shortcomings to this strategy. Firstly, there is too much transparency in the clinical trials data. This means that any gains from bribing FDA officials would be temporary, as any re-review of the data would reveal the weaknesses. Alternatively, if a company were to try to falsify the clinical trials data, they would have to bribe medical researchers in dozens of instituions; the presence of a single whistleblower would collapse the whole scheme.
Even if a company could bribe FDA officials, or if they succeeded in generating and submitting falsified clinical trials data, outcomes monitoring by healthcare payers and independent researchers would ultimately reveal any issues with safety or efficacy, and tort damages from unsafe drugs can quickly eclipse earnings.
Generic drugs: Too much to lose
The approval process for generic drugs is much simpler than for branded drugs, which means that far fewer people would need to be be bribed to influence approval. In fact, bribery has occurred in generic drug approval. In 1989 Mylan Laboratories, Inc. was successful in exposing bribery of FDA officials by other generic firms, which was causing Mylan’s generic submissions to be stalled.
Congress responsed by giving the FDA a punitive debarment process. through the 1992 Generic Drug Enforcement Act. Debarment prevents a person from working for a drug company in any capacity and may range from five years to a person’s lifetime. Further, companies employing debared people can be fined $1 million, and debared people working illegally can be personally fined $250,000.
Given the transparency and oversight in drug development, and substantial downsides of bribery, it is unlikely to be occurring in an appreciable capacity. Rather, given the opportunities for price gouging it would seem that that would be the preferable route for unsavory actors with short-term interests.Copyright © DrugPatentWatch. Originally published at Can Drug Companies Bribe the FDA?
Also published on Medium.