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The House of Representatives on Monday passed three bipartisan pharma bills, all by voice votes, aimed at promoting continuous drug manufacturing, the release of drugs from the Strategic National Stockpile and extending the FDA’s authority for counterfeit products. Read More
HHS has clarified that last week’s memo from Secretary Alex Azar will in no way impact the FDA’s decisions on drugs and vaccines although former FDA officials say questions remain. Read More
Coronavir, a treatment developed by Russian company R-Pharm for mild-to-moderate COVID-19 infections, is slated to be offered in pharmacies in that country as early as this week. Read More
HHS on Sunday refuted reports that a new departmental memo will take decision-making power away from the FDA regarding the approval of COVID-19 vaccines or therapeutics. Read More
Despite industry resistance and reluctance from state legislatures, the Trump administration is gearing up to issue a final rule allowing states to import prescription drugs from Canada as part of its campaign to deliver lower drug prices. Read More
Leaders of the House Energy and Commerce committee on Friday lashed out at the Trump administration for allegedly blocking Commissioner Stephen Hahn from testifying about the agency’s COVID-19 response. Read More
The Center for American Progress (CAP), a Democrat-aligned think tank, issued a report Thursday recommending how the next president could lower drug prices, such as by leveraging existing laws to break up drug monopolies. Read More
FDA’s Office of Prescription Drug Promotion (ODOP) slapped Sprout Pharmaceuticals with a warning letter over the misbranding of its drug Addyi (flibanserin) in a direct-to-consumer radio ad. Read More
More than 240 bipartisan lawmakers wrote to HHS Secretary Alex Azar this week urging the department to take immediate action to stop drugmakers from discontinuing or greatly altering the discounts they provide to safety-net hospitals as required under the 340B Drug Pricing Program. Read More
New York State’s surcharge on opioid drug manufacturers to help pay for the costs of the opioid drug abuse epidemic is a constitutional tax, the U.S. Court of Appeals for the Second Circuit ruled Sept. 14. Read More
Indian pharmaceutical company Dr. Reddy’s will assist in phase 3 clinical trials and distribution in India for Russia’s COVID-19 vaccine, Sputnik V, the company and Russian government announced. Read More