For congressional overseers, red flags fly over issues at FDA

FDA logoCongressional overseers of the federal agency that regulates drugs and medical devices have gotten red-flag warnings about problems at the Food and Drug Administration, including: two separate calls for improvements from lawmakers’ top watchdog; and an eyebrow-raising corruption case brought against an agency official by U.S. prosecutors and securities enforcement authorities.

As Stat, the health news site, has reported, the Government Accountability Office has criticized the FDA in reports, saying the regulatory agency has failed to plan how it will keep up with rapid advancements in medical science. Stat observes of the studies by GAO, Congress’ watchdog:

One report notes that the FDA lacks goals, targets, and time frames for keeping up with scientific advances—and also fails to track the money it spends on these efforts. The other finds fault with the FDA’s strategic plan, which is supposed to speed approvals of drugs and devices, especially combination medical products, such as heart stents that also deliver blood thinners to prevent clots.

The FDA critiques were released by Republicans in the U.S. Senate, as part of partisan wrangling over some biomedical bills and the 21st Century Cures Act, a measure that advocates say will speed drugs and medical devices to the market. Opponents, including many Democrats, are fighting this already-House passed bill, saying it benefits Big Pharma and device makers while undercutting patients’ health and safety.

Insider trading case raises concerns

Meantime, a criminal and securities fraud case involving a former FDA official is raising concerns, Stat reports separately. The former deputy director of the agency’s Office of Generic Drugs has pleaded guilty to securities fraud and three other crimes for sharing information with a hedge-fund about impending actions on medications. The Securities and Exchange Commission now has sued the official, who also served as a drug industry consultant, asserting he engaged in insider trading.

As Stat notes:

Insider trading appears to be a growing problem in the pharmaceutical industry as several cases have emerged. The issue has raised concerns in connection with clinical trial work, as well as deal-making and the FDA approval process, which some fear can be distorted by such activities.

FDA officials declined to comment on the case, including how the agency may be seeking to prevent corrupt practices like these.

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