Health Fears Prompt FDA to Mandate Change in Testosterone Labeling

The Food and Drug Administration (FDA) recently announced that it will require prescription testosterone manufacturers to label the drugs to warn users that they might face a higher risk of heart attacks and strokes. The agency also ordered the drug makers to list the approved uses of testosterone medications on their products. Continue reading

FDA Moves to Make Generic Drugmakers More Accountable

Generic drug makers, who fill 84% of prescriptions in the U.S., are required to copy the labels of their brand-name equivalents verbatim. Because they have no control over the safety warnings’ content, the U.S. Supreme Court ruled in 2011 that generic drug manufacturers cannot be held liable if the drug ends up hurting a patient.  Continue reading

Risk to Consumers from Unregulated Compounding Pharmacies

Recent events, as reflected in these Austin American-Statesman articles, illustrate the risk to consumers from virtually unregulated compounding pharmacies. The magnitude of the harm that can be caused by these medications is enormous, and there is little consumers can do to assure themselves that materials injected into their bodies are safe. Continue reading

FDA Acts on Generic Drug Safety

Reading this article from The New York Times, it is encouraging to see that the FDA may make new rules requiring generic drug manufacturers to update drug labels with new safety information. What remains to be seen is whether the new rules will open the door that the Supreme Court says is closed to people seriously injured by generic drugs. Continue reading

New Antibiotics vs. Safe Antibiotics

As this NPR story points out, antibiotics research is crucial. Antibiotics save lives. That is why it is vitally important that antibiotics be as safe as possible. Drug companies that have stopped developing new antibiotics might renew development efforts if a) they are allowed to cut corners and b) the FDA applies a “lower standard” with respect to proving that the drug is safe. Continue reading