FDA issuing more warnings, as doctor confidence in regulators remains shaky
In the first half of 2005, the agency issued double the number of public advisories about drug risks as it did a year ago--11 versus five for all of last year and two in 2003--and has added five times as many black-box warnings to drug labels--45 versus nine during a similar period last year, according to the article.
The FDA also is taking more time to review NDAs. The average time from application to approval for drugs approved during the first half of 2005 was 29 months, compared with an average of 16 months for drugs approved in the first half of 2004. The agency also is increasingly asking drug makers to study the safety of their products after they hit the market.
Two episodes over the past year have led to the more conservative stance: one involving antidepressants and suicide risk and the other the withdrawal of Vioxx.
FDA officials dismiss the notion that they are becoming too conservative, with one saying the agency is simply following the lead of its advisory committees. Others say it is trying to do a better job communicating drug risks directly to doctors, pharmacists and patients after years of letting drug makers do most of the talking.
Lester Crawford, FDA commissioner, has said the agency can no longer wait until risk information is proved but must communicate its uncertainty to the public.
But physicians say they are confused by FDA's vague warnings about uncertain risks and that the agency's credibility has been shaken.
Confidence among physicians in current regulatory approval guidelines was seen as low, and even lower with regard to post-market monitoring, according to a survey commissioned this year by management consulting firm Accenture. Researchers surveyed 100 doctors, including family physicians, general practitioners and internists. Half indicated they are only "somewhat" confident in the ability of regulatory approval guidelines to ensure drug safety, with only 47 percent somewhat confident in post-market monitoring.
Half said that recent drug recalls don't reflect a failure on the part of regulatory agencies, although a sizable minority, 38 percent, said that recalls do represent a lapse in regulatory guidelines.
Most (80 percent) physicians said regulatory agencies could do more through post-marketing monitoring and that agencies should improve their ability to get feedback on monitoring efforts (77 percent). Only 23 percent of doctors felt extending testing time before a drug goes to market would help protect patients more.
A similar percentage of consumers (88 percent) said more could be done to monitor the safety of drugs once they are on the market, according to the study, which included interviews with 524 consumers over age 30. A majority (71 percent) said more could be done to ensure drug safety.