Health Care & Prescription Drugs News

California bill will prod national decision makers, serve in lieu of federal policy if Congress fails to act

SACRAMENTO—The California Assembly Health Committee passed the Pharmaceutical Drug Information and Safety Act, SB 606 (Scott), today with all members present voting in favor of the bill. The measure will require pharmaceutical companies to disclose the results of clinical studies, meaning that doctors, patients, researchers and even industry competitors will gain access to information on the side effects and effectiveness of medicine currently on the market.

“Asking doctors to write prescriptions without access to all the studies is like asking legislators to pass a bill without letting them see each of the measure’s provisions,” said Steve Blackledge. “The system can’t work that way, and we’ll end up with tragedies like the ones triggered by Vioxx.”

In the Vioxx case, Merck uncovered information in a clinical study showing an increased risk of heart attacks and strokes but was not required to make that information public. Meanwhile, the company continued to aggressively tout its drug until it was pulled from the market, and Merck is now bogged down in litigation.

Federal lawmakers have passed legislation in the U.S. Senate to address drug safety concerns, and the measure, known as the Kennedy-Enzi bill for its authors or simply as S. 1082, includes a provision that requires public disclosure of the results of clinical studies. The federal bill leaves the details to be worked out through a rulemaking process.

“We support the federal bill that passed the Senate, as well as the measure that will pass soon—knock on wood—in the U.S. House, but California is not a state to twiddle its proverbial thumbs waiting for Congress to act,” said Blackledge. “We wanted to move quickly in California in case the feds dilly dally too long or simply do nothing.”

In addition to CALPIRG, the sponsor, supporters of the measure are the California Academy of Family Physicians, California Nurses Association, California Board of Pharmacy (a board within the California Department of Consumer Affairs), Latino Coalition for a Healthy California, Consumers Union, California Labor Federation (AFL-CIO), Health Access, Congress of California Seniors, the California Association of Retired Americans, Greenlining Institute, AIDS Health Care Foundation, Consumer Federation of California, Breast Cancer Action and others.

“We thank the Assembly committee members for siding with the public, and we thank Senator Scott for his perseverance on this bill,” said Blackledge.

The bill now moves to the Assembly floor. The major impetus for the unanimous vote was a new set of amendments that gave the industry additional time to prepare the results of the study and require the industry to produce clinical studies going back to 2002, whereas 1997 was the previous requirement.

Blackledge noted that the new amendments removed much of the industry opposition, clearing the way for this bill to pass the committee and get signed into law.