New Drug Safety Bill Introduced in Senate

Published September 1, 2006

In a bid to increase federal scrutiny of the safety of pharmaceutical industry products, U.S. Sens. Michael B. Enzi (R-WY) and Edward M. Kennedy (D-MA) unveiled the Enhancing Drug Safety and Innovation Act of 2006 in late July.

The legislation aims to change testing, labeling, and approval processes for medications nationwide by amending the Public Health Service Act and the Federal Food Drug and Cosmetic Act “to improve drug safety and oversight, and for other purposes,” according to the text of the bill.

The bill also includes provisions for establishing a new federally funded biomedical research institute and a federal database of clinical trials and their results, and mechanisms to resolve conflicts of interest on Food and Drug Administration (FDA) advisory committees.

The legislation would provide “a rapid, consistent framework for making changes” to drug labels and new rules governing the results of clinical trials, according to a statement from Kennedy’s office.

“It’s critical that the FDA be given the ability to ensure that the risks of prescription drugs are adequately assessed and managed, so that drugs can be safely used by patients,” Kennedy said.

Increased Scrutiny

Enzi spokesman Craig Orfield concurred.

“The health committee hearings brought consensus regarding safety in light of Vioxx and other similar issues, as well as concerns regarding the pace of approval,” Orfield said. Last year’s Senate Committee on Health, Education, Labor, and Pensions hearings on drug safety led members to believe more comprehensive measures were needed.

Vioxx, an anti-inflammatory arthritis medication manufactured by Merck & Co., was withdrawn from the market after it was found to increase the risk of heart attacks and strokes. A joint investigation by the U.S. Justice Department and Securities and Exchange Commission in 2004 prompted the Senate hearings that resulted in the new bill.

The Pharmaceutical Research and Manufacturers of America, a Washington, DC-based group representing drug companies, adopted a neutral tone toward the Enzi-Kennedy bill.

“We believe FDA’s rigorous review process is critical to ensuring American patients receive the highest quality prescription drugs,” Senior Vice President Ken Johnson said. “Clearly, the U.S. safety record is unmatched: Fewer than 3 percent of approved prescription medicines have been withdrawn from the market over the last 20 years. For America’s pharmaceutical research companies, safety is our top priority, and it always will be.”

David Salvo ([email protected]) is a freelance writer living in Bloomington, Indiana.

For more information …

The 99-page text of the Enhancing Drug Safety and Innovation Act of 2006 is available at