LANSING – The Michigan House Tort Reform Committee will take up legislation to eliminate product liability immunity for prescription drugs, but not until committee members have a better understanding of the drug approval and tracking process.

The committee received an overview of the drug approval process from U.S. Food and Drug Administration officials on Tuesday, but committee Chair Rep. Kevin Elsenheimer (R-Bellaire) said there were still some questions to be answered.

“We’re planning to have some testimony on the bill itself, but I would like to close the loop on some of these FDA issues first,” he said. Among the outstanding issues is how exactly the FDA learned of the issues with Vioxx and related drugs and what the process was to get the drug off the market, as well as how new physician liability rules will work.

Elsenheimer said he expected one or two more committee conversations with FDA officials before opening up testimony on HB 5527 , the bill that appears most likely to move on the issue. But he said there would be public hearings on the legislation before summer break.

FDA officials walked the committee through the process of having a new drug approved as well as the continued monitoring and testing required once it is on the market.

Bronwyn Collier, associate director of regulatory affairs for the FDA Office of Drug Evaluation, said drugs are thoroughly tested before being licensed for sale, but she said the testing is done on limited populations and the true extent of side affects is often not clear until the drugs hit the market.

“Things that occur uncommonly are not necessarily apparent during the study but become apparent after marketing,” she said. “The mass of information about the drug improves.”

And she said drug companies are required to notify the agency within 15 days of any findings of potential safety issues with the drug.

The agency also accepts complaints and other information from the general public and can launch investigations based on those communications.

But Collier did not have any information on the specific steps in the process that led to taking Vioxx and some other Cox 2 inhibitors off the market. The drugs were used as anti-inflammatories for those with arthritis, but have been linked to heart attacks and strokes.

Vioxx was among the drugs that led to the current push to change Michigan’s product liability laws, which provide immunity to drug companies as long as the drug was properly approved by the FDA.

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