Calif. Lawmakers to Address Nine Prescription Drug Bills

A California state bill requiring drugmakers to turn over all safety and effectiveness data on every drug product sold in the state is part of a batch of Rx-related legislation that California lawmakers are scheduled to address this session.

Assembly Bill (AB) No. 72 would require a manufacturer that markets a drug product in California to submit a report containing every study that has been or is being conducted on that product, whether the results are positive, negative or inconclusive. A drugmaker that violates the requirement would be liable for civil penalties of up to $25,000 for each first violation, up to $100,000 for each second violation, and up to $200,000 for each subsequent violation.

The proposal was among nine prescription-drug-related bills introduced recently by a coalition of Assembly Democrats, led by Assembly Majority Leader Dario Frommer. The package of bills aims to lower the rising costs of prescription drugs and address the "growing concern about the safety of FDA approved medications," according to Frommer.

One of the bills addressing safety, AB 71, would establish a California Drug Safety Watch office to compile data about adverse reactions from consumers who use prescription drugs. "Although the FDA is responsible for postmarket surveillance of prescription drugs, numerous concerns have been raised about the adequacy of these efforts," according to the bill's text. Pressure to get new drugs to market, combined with the billions of dollars spent on drug marketing, makes it difficult to address a safety threat once it is identified, the bill said.

PhRMA declined to comment on the California proposals until it has had a chance to study the legislation.