More power to FDA on drug safety

May 10 2007

The Senate overwhelmingly passed significant prescription drug safety reforms to give the Food and Drug Administration more power to deal with unsafe medicines on the market, moving the issue of drug safety to the House, where a strong bill has been introduced but has yet to be considered.

"The Senate should be congratulated for passing reforms to ensure patients and doctors know more about the risks of their medicines," said Bill Vaughan, senior policy advisor for Consumers Union, publisher of Consumer Reports. "The leadership of Senators Kennedy and Enzi on drug safety reform has been invaluable to getting this through the Senate."

"Too many lives have been lost because the FDA has been too slow to act, or didn't have the power to change a warning label or require a follow-up safety study. It's now up to the House to get the strongest possible reforms approved so patients can have faith in the medicines they take each day," Vaughan added.

S 1082, passed by a 93-1 vote, gives the FDA power to change drug labels and require post-market studies for drugs that have safety problems. It also requires drug makers to register most of their clinical trials - although the legislation gives the FDA 2 1/2 years to develop guidelines for making some, but not all, clinical trial results public.

Consumers Union is urging the House to pass language to make all clinical trial results public immediately to prevent drug companies from downplaying studies which reveal harmful side effects, as was the case with Vioxx and Paxil.

On the issue of direct-to-consumer advertising, an original provision in the Senate bill giving the FDA power to restrict advertising for new drugs with safety indications was removed. It was replaced with a much weaker measure that only allows the FDA to fine companies ($150,000 per violation) for ads that are false or misleading when it comes to disclosing a "serious health risk." With new drugs, serious health risks often aren't clear until a drug has been on the market for years and used by millions, which is why having the DTC moratorium option is critical for safety.

"While it's important FDA has the power to hold a drug company's feet to the fire when it comes to misleading ads, we'd urge the House to support restrictions on massive ad campaigns for those new drugs with early danger indications," Vaughan said. "There is nothing in the First Amendment that guarantees drug companies can push medications with health risks on the public. When a company can make more than a million dollars a day in drug sales, a $150,000 fine for running a misleading advertisement won't have much impact."

HR 1561, introduced by Reps. Waxman and Markey, contains many of the Senate provisions, but makes more clinical trial results available more quickly, and allows for a three-year advertising moratorium on new drugs with safety issues. It is unclear whether that bill will move alone or be attached to a broader drug-user fee renewal measure like the Senate version.

"The House bill has some stronger safety measures that would close loopholes the drug industry could exploit when it comes to making risk information public," Vaughan said.

In the Senate bill, an amendment offered by Sen. Grassley (R-Iowa), to give the FDA's drug safety office a higher profile by giving it joint decision-making with the Office of New Drugs over drugs on the market lost by just one vote. CU supported the amendment because those in the FDA responsible for safety "are often overwhelmed, ignored, or even told to be quiet."

The Senate also approved amendments that would:

• Impose higher fines on companies that fail to comply with risk mitigation strategies, such as performing post-market safety studies. "We have seen repeated violations of drug-company promises to comply with FDA requests, and the agency desperately needs tools to ensure companies keep these promises," Vaughan said.
• Help get affordable generic medicines on the market more quickly by blocking the frivolous use of citizen petitions to delay the entry of generics on the market. Only three of 42 citizen petitions answered between 2001 and 2005 raised issues that merited changes in the agency's policies about a drug, yet they can often delay generic getting on the market.
• Improve food safety by developing a registry of dangerous food contamination incidents, and work with states to strengthen standards and procedures to improve safety of processed produce. The amendment from Sen. Durbin (D-Ill.) also directs FDA to issue processing, ingredient and labeling standards for pet food.

"The is a useful first step, but Congress needs to do much, much more if we are to avoid continued problems like we have had this year with spinach, peanut butter, and pet food," said Sally Greenberg, senior policy analyst. "Food safety, like drug safety, is a major concern for American families, and consumers want strong laws to ensure their food is as safe as possible."

Consumers Union supports legislation that would give the FDA mandatory recall authority over tainted food -- currently food recalls are voluntary -- and the creation of a single food agency to coordinate oversight of safety functions, which currently is split among 15 federal agencies.

Sens. Dorgan and Snowe's drug reimportation proposal was effectively negated by an amendment requiring the FDA to certify all reimported drugs safe, which the FDA has been reluctant to do. Consumers Union urges Congress to reconsider drug reimportation later this session to provide some immediate, needed financial relief for Americans who can't afford their medications.

"Reimportation is an important interim step to immediately helping those Americans who can't afford their needed medications, but long-term solutions to spiraling drug costs are still needed," Vaughan said. "Congress and the administration should enact domestic drug price negotiation laws like those the Veterans Administration uses to ensure all of us can purchase at home the safest and most affordable medications available."