At the University of Pennsylvania, researchers doing thalidomide trials have sought out women who cannot bear children. We're also planning to carefully follow up with physicians. Peter Andrulis aims to protect his company as well as clinical trial patients. At Andrulis, women in clinical trials get weekly doses of thalidomide. Before receiving a dose, the women must obtain a negative result from a pregnancy test.
Patients also use two forms of contraceptives while taking the drug.
FDA's Birnkrant says the agency might like to conduct similar pregnancy testing of patients if thalidomide does get approved. Peter Andrulis, president of Andrulis, says the company will create what he calls an 'onion skin' approach -a layer of pregnancy protection, under another layer, under another. He hopes to protect both the women and the company itself. One concern for both Accutane and thalidomide manufacturers is that doctors might prescribe the drugs outside their intended market. If a drug is effective against just one disease, you could focus on just one market.