Washington Report: A Warning Trend - Pharmaceutical Executive


Washington Report: A Warning Trend
Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf?

Pharmaceutical Executive

Now emerging safety problems are encouraging its critics to try to kill RU-486 altogether. Scientists and regulators hope to address the medical issues involving this drug at a private meeting sponsored by the Centers for Disease Control and Prevention (CDC). The question is whether the deliberations can be kept focused on the medical issues.

Supposed safety concerns might also provide an excuse to keep the over-the-counter version of the emergency contraceptive Plan B off the market—perhaps the most heated issue on the science-versus-politics debate list. At the recent House committee hearing on FDA's budget for 2007, members of Congress took acting commissioner Andrew von Eschenbach to task, demanding to know what he was doing to end the delay. FDA's leader pointed out that the agency had 10,000 comments on the issue to analyze, and avoided making predictions on the prospects of a final decision.

Meanwhile, a number of states have approved OTC versions of the drug, a situation that undermines FDA efforts to persuade state regulators to defer to labeling decisions made by the federal agency. FDA and industry don't want 50 different policies governing medical-product marketing, but FDA has only it own inaction on Plan B to blame for compromising its preemption claims.

Going Public

To deal with mounting safety controversies, FDA has adopted a more open approach to disclosure. When data appeared in February indicating that the Ortho Evra birth control patch might increase the risk of blood clots, agency officials held a press conference to explain why they await further analysis, rather than immediately pull the product off the market.

Johnson & Johnson's Ortho-McNeil unit has obtained conflicting preliminary safety results from two epidemiologic studies. One study indicated no increased risk of heart attack and stroke compared with pills, but the other showed a two-fold higher risk of blood clots. Because the patch is beneficial to women who have trouble taking a pill every day, FDA wants to wait and see before curbing access to the product. In fact, FDA has just announced that it will launch a broader study of patch safety.

At the same time, the need to prevent pregnancy among women taking Roche's acne medication Accutane and generic isotretinoin prompted FDA to go ahead with an aggressive risk management program for the drug. The iPledge program requires physicians, distributors, pharmacists, and patients to register; women who take the drug have to use two forms of birth control and submit monthly pregnancy test results.

Dermatologists pressured FDA to postpone implementing this complex program until sponsors fix glitches in the registration and verification process, but FDA officials emphasized the importance of taking steps to prevent pregnancy among Accutane patients. Past risk management initiatives have not worked, and the agency said it's time for doctors and pharmacists to get with the program, despite its Big Brother characteristics.

No Oversight? FDA's Drug Safety and Risk Management Advisory Committee didn't limit itself to criticizing drugs at its February meeting. It also had a few words for the agency's Drug Safety Oversight Board (DSOB). Formed about a year ago as a forum for internal FDA discussion of drug safety, the board has been criticized for operating behind closed doors and limiting membership to FDA and other government personnel. FDA explains that DSOB is not a public body, but the confusion persists—partly because of the board’s name, which implies broad oversight functions.

One anticipated task for DSOB is to decide which emerging drug safety issues should be posted on a planned FDA Drug Watch Web site. The idea was to reveal emerging safety signals gleaned from databases and adverse event reports before waiting for a full analysis to confirm a real problem. But pharma companies have objected loudly that such disclosure could raise needless fears among patients, along with serious liability threats. FDA says it's re-examining the Drug Watch plan, but is under pressure to publicly disclose safety concerns whenever they appear.

Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at


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