FDA Reform by the Numbers

It's crunch time in the Senate on Food and Drug Administration reform. The Health Education Labor and Pensions committee, chaired by Sen. Ted Kennedy, will hold a mark-up hearing next week on a bill that lumps together safety, generic biologics, medical devices and pediatric drugs. Lobbyists will get to see the first draft of the bill later this morning.

I'll have more to say on its contents after I see it. But here's a few public opinion measuring points:

Will it give adequate new powers to the FDA to pull unsafe drugs off the market? According to a recent Consumer Reports poll, 58 percent of the American public are either "very concerned" or "concerned" about the safety of prescription drugs.

What new limits will it put on direct-to-consumer advertising? Just under 60 percent "strongly agree" that advertising should be prohibited if there are safety concerns about a drug. There is strong pushback from the drug industry lobby about limiting commercial "freedom of speech."

Will it require public disclosure of the results of all clinical trials, whether or not they were submitted to the agency for getting a new drug approved? Fully 68 percent of the public "strongly agree" to full disclosure.

Will companies be punished if they don't complete in a timely fashion follow-up trials ordered at the time of drug approval? Again, two-thirds of the public want those studies done.

And, finally, will it prohibit the FDA from hiring outside advisers who have financial ties to the companies (or their competitors) whose products are being evaluated? Two-thirds of the Consumer Reports poll expressed deep concern about these conflicts of interest, mirroring a Harris Interactive poll from last summer which showed that 70 percent of the public thought they ought to be banned.

Meanwhile, billions of dollars are at stake in the generic biologics portion of the bill. With three-quarters of the American public worried about the rising cost of drugs (despite the new Medicare prescription drug benefit), will the bill provide an easy pathway for firms seeking to bring generic versions of complex proteins to market once the original goes off patent?

According to lobbyists for generic manufacturers like Barr Laboratories, the science isn't as complex as Amgen, Gemzyme and Genetech (makers of Epogen, Cerezyme and Human Growth Hormone, respectively) have claimed. The FDA's top officers have testified before Congress that they have the technical expertise to determine that generic biologics are comparable to the original version without demanding the full range of human clinical trials.

It will be interesting to see how the Senate's HELP committee, now under Democratic leadership, resolves these questions. Will it side with the people, or will it bend over backwards to accommodate the drug and biotechnology industry lobbyists who are swarming over Capitol Hill?

Posted by gooznews at April 11, 2007 08:38 AM