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Gilead Sciences has agreed to pay $97 million to settle Department of Justice (DOJ) claims that it illegally channeled Medicare copays for its pulmonary arterial hypertension (PAH) drug Letairis (ambrisentan) through a charitable foundation. Read More
In a letter to Eli Lilly this week, HHS General Counsel Robert Charrow rebuked the company over its plans to cut discounts offered through the federal government’s 340B Drug Pricing Program. Read More
The head of the FDA’s vaccine advisory committee has recused herself from its upcoming COVID-19 vaccine review to avoid any appearance of a conflict of interest stemming from her leadership role in Moderna’s vaccine trial. Read More
In a letter sent yesterday, leaders of the House Energy and Commerce Committee demanded that the HHS Office of Inspector General (OIG) conduct a full investigation into politically motivated interference by the White House in the affairs of the Centers for Disease Control and Prevention (CDC) during the pandemic. Read More
New York Gov. Andrew Cuomo is threatening not to distribute FDA-approved COVID-19 vaccines in his state until they receive approval from a state task force of scientists, doctors and health experts. Read More
“This settlement demonstrates the government’s commitment to hold accountable companies that pay illegal kickbacks, whether directly or through a third party,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the DOJ’s Civil Division. Read More
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Thursday that White House interference with the FDA’s policies for authorizing a COVID-19 vaccine would be “troublesome.” Read More
HHS yesterday unveiled the much-anticipated final rule allowing imports of prescription drugs from Canada, delivering on a Trump Administration promise ahead of the presidential election. Read More
The European Commission’s (EC) contracts with COVID-19 vaccine suppliers include limited indemnity against liability in case of unexpected side effects, the president of a European vaccine trade group said this week. Read More
The Government Accountability Office (GAO) has proposed that the FDA’s drug evaluation, biologics evaluation and medical device centers implement formal equipment management policies after finding that their current procedures need improvement. Read More
The FDA has announced that it is requiring an update to the Boxed Warning for benzodiazepines to include the risks of abuse, physical dependence and withdrawal reactions associated with their use. Read More
In a stunning departure from how FDA guidances are issued by the agency, President Donald Trump said Wednesday evening that he might move to reject a guidance that is expected to impose stricter thresholds for any COVID-19 vaccine Emergency Use Authorizations (EUAs). Read More