Healthy Skepticism Library item: 12470

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Publication type: news

Silverman E.
US Senator Wants To Probe FDA Fast Track Program
Pharmalot 2008 Jan 11
http://www.pharmalot.com/2008/01/us-senator-wants-to-probe-fda-fast-track-program/

Full text:

Sherrod Brown, a Democrat from Ohio, has asked the research arm of Congress for information on the Fast Track designation to help determine whether a case exists for changing or eliminating the 10-year-old initiative that was intended to speed the availability of drugs for serious diseases, The Cleveland Plain Dealer reports.

The senator filed the request with the Congressional Research Service following a series in The Plain Dealer last month that concluded the FDA designation provides little actual benefit to consumers. The paper found that the designation has amounted to a government blessing, which has served as a marketing tool for drugmakers and a boon for investors looking to make quick money on the stock market.

Brown says the research will cover the various FDA programs to develop and review drugs and will help provide an assessment of Fast Track’s impact in preparation for discussions with senate colleague Edward M. Kennedy, a Massachusetts Democrat. Brown is a member of the Health, Education, Labor and Pensions Committee chaired by Kennedy.

“We’ll have a better understanding then, when I go to Kennedy and his people to talk about this,” Brown said. “They can see what they want to do then.” Congress approved the Fast Track designation in 1997 as part of extensive legislation to streamline the system for approving drugs and medical devices.

Kennedy played a major role in the creation of the designation. According to press reports at the time, he worked closely with the Genzyme, a Boston biotech that was a driving force behind the measure. A Kennedy spokeswoman says patient groups advocated for the designation, and the senator supported it because people were “suffering and dying needlessly.”

But if profiting on the stock market has been an unintended consequence of Fast Track, Congress should make necessary changes, Kennedy now says.

“Fast Track designation is meant to speed the review of urgently needed medicines, and it should not be abused to artificially inflate a company’s profits,” Kennedy says in a statement provided by his staff. “Congress should see that the Fast Track process is not abused and retains its intended purpose of seeing that important new medicines reach the patients who need them without undue delay.”

Since 1998, The Plain Dealer’s examination found, Fast Track announcements for almost 200 drug treatments triggered one-day stock price increases that averaged 10 percent. The announcements also created quick profit opportunities for day traders and hedge funds, driving one-day increases in shares bought and sold to an average of 1,300 percent. Frequently, company announcements erroneously suggest the designation is an indicator that a drug is likely to be approved.

A top FDA official acknowledged that Fast Track gives drug companies access to the same programs that were in place before the designation and provides no unique benefits to speed the development and approval of drugs.