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Klobuchar Votes to Improve Consumer Prescription Drug Safety

Bill strengthens safety for children, allows for better labeling of medications with risks

May 9, 2007

(Washington, D.C.) Today U.S. Senator Amy Klobuchar voted in support of legislation that will strengthen consumers' medical safety. The bill, S. 1082, The Food and Drug Administration (FDA) Revitalization Act, will help make medicines and medical devices safer for children, require better labeling of the risks that medications carry with them to protect consumers, and establish a system of routine active surveillance measures for prescription drug safety. Klobuchar strongly supported an amendment to remove federal barriers to re-import lower-cost prescription drugs from countries like Canada.

"This legislation takes a step toward making sure that prescription drugs are safe for our people," remarked Klobuchar. "We fought hard to allow the importation of prescription drugs to make medications more affordable for our citizens, and I will continue to fight for measures that help our families pay their medical bills and provide for their families."

The legislation provides the FDA with the oversight it was lacking to monitor prescription drugs after they hit the market. Inadequate oversight resulted in aggressively marketed medications like Vioxx, an arthritis medication, harming patients with adverse effects like heart attacks.

Klobuchar stated, "It's the FDA's job to make sure that when someone goes to the doctor they know, right on the bottle of their medicine, what risks it might have. It's our job to see to it that the FDA can keep people safe and that's what we did with this bill today."

The bill also reauthorizes and improves the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Improvement Act (PRIA), which have had proven success in providing incentives for drug manufacturers to develop pediatric drugs; giving pediatric medications priority status for FDA evaluation; and promoting the dissemination of information related to pediatric drugs for better public safety.

Other provisions of the legislation will help coordinate investors with researchers to facilitate the development of new pediatric medical devices, provide assistance to innovators, and allow the FDA to monitor pediatric devices and make recommendations for improving their availability and safety.

"It is simply common sense to make sure our kids have the best medicines and the best devices available for them to get better when they are sick," said Klobuchar.

The legislation establishes a review process for prescription drugs called a risk evaluation and mitigation strategy (REMS). This will allow the FDA to oversee that drug manufacturers appropriately design and conduct post-market (after a drug has been introduced into the market) studies and disclose results to the public in prescription drug literature and labeling.

The process mandates that all medications have: 1) FDA-approved professional labeling stating any known or possible health risks; and 2) a timetable for periodic assessment of the REMS. For drugs with out-of-the-ordinary risks, the REMS could include additional elements to protect patient safety, such as special training for doctors who prescribe the drug, and additional studies conducted after approval.

"This bill allows for innovation in new medicines and devices to help our people stay healthy, while allowing the FDA to keep a watchful eye on our safety and take appropriate action to protect consumers," commented Klobuchar"

A company who knowingly fails to comply with FDA safety provision would be subject to civil monetary penalties and the FDA retains its traditional enforcement tools, such as seizure of drug products or court injunctions.

The legislation passed by a vote of 93-1.

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