One of the chief concerns involves the possible creation of an independent office to review post marketing studies.
"A lot of proposals are floating around and a number of senators are considering legislation," notes Sara Radcliffe, managing director of science and regulatory affairs, BIO.
In testimony before the Senate Finance Committee last Novem-ber, David Graham M.D., associate director for science and medicine in the FDA's Office of Drug Safety, questioned the wisdom of having post-marketing studies conducted by the same office that "approved the drug in the first place and regards it as its own child."
However, "a separate entity has drawbacks," says William Janssen, J.D., partner and chairman of life sciences at Saul Ewing (www. saul.com). "You're taking the body most familiar with a drug and divorcing it from the post-marketing side. To abandon that learning seems imprudent."
Another concern includes speculation that clinical trials may become harder to enroll.
"When I was taking care of patients (and participating in clinical trials), I trusted that the pharmaceutical company was giving me as much up-to-date information as it had," says Jeffrey Green, Pharm.D., CEO, DataTrak International (www.datatraknet.com).
"Now, I would be very resistant to talking a patient into entering a clinical trial. If a physician sees only the 10 to 20 patients he or she enrolled in a given trial, there's no way to see the larger trends quickly."
Other concerns, cited by the editors of the Journal of the American Medication Association (JAMA), in an editorial posted November 22, included "reliance upon manufacturers for collecting, evaluating, and reporting data from post-marketing studies of their own products, poor quality of submitted reports, underreporting of adverse outcomesand difficulty in determining whether the adverse event resulted from the drug or the disease it was intended to treat."
Some of those issues relating to timeliness of information and reporting quality could be addressed by using electronic data capture during clinical trials, Dr. Green says. One of the issues, he continues, is "did Merck have a failure to know, in a real-time fashion?" Paper-based data can take six to nine months to be integrated into a database and analyzed, whereas "an electronic data capture system can track events within 10 seconds."
The FDA is phasing in electronic submissions. "But, I'm not sure they're really pushing for it," adds Dr. Green. "They have guidelines," but they should insist on having data in a live database by a certain timeframe.
"The Securities and Exchange Commission instituted EDGAR several years ago and implemented it within a few months. Therefore, financial information has a higher priority than patients' adverse events," maintains Dr. Green.
Part of the problem, according to James Walsh, author of Silverlake Publishing's "Liberty in Troubled Times," is the "revolving door between the FDA and industry. It's a standard career path to rise through the agency and end up working for drug companies and, most disturbingly, to come back to the FDA."
The issue, he continues, "is not that it colors any one decision, but that it colors them broadly," by causing the agency to focus on the issues the industry wants addressed, rather than the issues that most need addressing. "The most profound way industry can influence their regulators is to hug them to their chests," notes Walsh.