House of Representatives Set to Vote on Tough New Drug Testing Standards

After an epidemic of drug-safety recalls, Congress is getting serious with pharmaceutical companies. The House of Representatives is scheduled to vote Wednesday on HR 2900, the Food and Drug Administration Amendments Act of 2007. According to a press release from Consumers Union, the act, which already been passed by the Senate, marks the biggest change to the FDA in 45 years and calls for $400 million in increased fees to pay for safety testing.

The House version of the bill goes even further than the Senate's bill by giving the FDA broader powers to order safety studies after new drugs have hit the market and requires drug companies to retest medicines after they have been available for seven years. The House bill also hits the trend of Direct to Consumer advertising. The bill would give the FDA the right to view DTC ads before they hot the airwaves, and would increase the penalty for misleading advertising. Companies would also be required to include a toll-free number along with a website for patients to report adverse reactions to the FDA in all DTC advertising.

Unlike the previously passed Senate bill, the House bill also limits the number of conflict of interests a drug panel can obtain to just one. Panels that currently recommend drugs for approval often include members with financial interests in the drug's approval.

The House bill also requires the creation of a drug study database so that doctors, researchers and patients can view the results of clinical trials, along with side effects.

The Consumers Union, the publishers of Consumer Reports magazine, has lobbied hard for the passage of both bills and is pushing Congress to send a strong bill to the President. Jim Guest, president of Consumers Union, sent a letter to House Majority Leader Nancy Pelosi. In the letter, Guest said ""This is the strongest improvement in the Food and Drug Administration in 45 years and it will help ensure safer prescription drugs for future generations of Americans." He added, ""The public simply has not been given the full story about all the potential risks of medications. That is why Congress must pass this bill, which will significantly strengthen our drug safety laws and adequately fund safety efforts at the FDA."

In the past five years, drug companies have been plagued by high-profile recalls of blockbuster drugs like Vioxx, Zelnorm, Propulsid, Permax and Tequin. Many of the products increased the risk of serious cardiovascular complications such as stroke, heart attacks or blood clots.

Source: Press Release: House Vote Set Wednesday on First Major Prescription Drug Safety Improvements in Nearly Half Century- (http://www.consumersunion.org/pub/campaignprescriptionforchange/004695.html)