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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
A COVID-19 vaccine won’t be widely available nationwide until late in the second quarter or in the third quarter of 2021, Robert Redfield, director of the Centers for Disease Control and Prevention (CDC), said yesterday at a subcommittee hearing of the Senate Appropriations Committee. But President Trump disputes that timeline. Read More
Drugs and biologics may fit into one of four categories when it comes to their use in patients age 65 and up, the FDA says in a new draft guidance on geriatric information for prescription product labeling. Read More
A top Roche executive slammed President Trump’s expanded “most favored nations” executive order as an unwise and overreaching policy for reducing U.S. drug prices, contending that the president’s own economic advisers found foreign price comparisons would hinder access to new medicines. Read More
In letters sent yesterday, leaders of the House Energy and Commerce committee urged nine companies developing COVID-19 vaccines to uphold their pledge to maintain high ethical standards and to commit to transparency in making all clinical trial data on their vaccines publicly available. Read More