Daily Briefing

Around the nation: AbbVie leaves top pharmaceutical trade groups


AbbVie has ended its membership with several major pharmaceutical and business lobbying groups, in today's bite-sized hospital and health industry news from Illinois, Maryland, and Virginia.

  • Illinois: AbbVie has decided to leave several major lobbying groups, including the Pharmaceutical Research and Manufacturers of America, the Biotechnology Innovation, Organization, and the Business Roundtable. "We regularly evaluate our memberships with industry trade associations and our most recent assessment led us to decide not to renew our membership with select trade associations," said an AbbVie spokesperson, who did not give a reason for the company's departure from the trade groups. According to Politico, this decision comes as regulators begin to implement the Inflation Reduction Act, which will allow Medicare to negotiate prices for certain drugs. Previously, AbbVie's CEO Richard Gonzalez had pushed back against the law's drug pricing provision, calling them "price controls" instead of negotiations. (Payne/Mahr, Politico, 12/15; Becker, Fierce Pharma, 12/16)
  • Maryland: FDA on Friday approved the first gene therapy for non-muscle-invasive bladder cancer that is unresponsive to bacillus Calmette-Guérin (BCG) treatment. The new treatment, nadofaragene firadenovec (Adstiladrin), is an adenoviral vector-based product. According to MedPage Today, the approval was based on a multicenter clinical study of 157 patients. In the study, the patients received Adstiladrin once every three months for up to 12 months, and the complete response rate was 51%, with half remaining in complete response for at least a year. "This approval provides healthcare professionals with an innovative treatment option for patients with high-risk non-muscle-invasive bladder cancer that is unresponsive to BCG therapy," said Peter Marks, director of FDA's Center for Biologics Evaluation and Research. "Today's action addresses an area of critical need. The FDA remains committed to facilitating the development and approval of safe and effective cancer treatments." (Bassett, MedPage Today, 12/19)
  • Virginia: The Drug Enforcement Agency (DEA) on Thursday alleged Truepill wrongfully filled thousands of prescriptions for ADHD medications. Through an investigation, DEA said it found that some prescribers did not have proper state licensing while others did not adhere to the 90-day supply limits. Overall, the agency said more than 60% out of the 72,000 prescriptions for controlled substances fulfilled by Truepill from September 2020 to September 2022 were for stimulants, including generic forms of the ADHD medication Adderall. "In numerous instances, Truepill dispensed controlled substances pursuant to prescriptions that were not issued for a legitimate medical purpose in the usual course of professional practice," Truepill has been served with an order to show cause, which could determine whether its DEA certificate of registration should be revoked. In a statement, a Truepill spokesperson said the company has received the order and is fully cooperating with it. "We are confident we will be able to demonstrate the absence of wrongdoing," the spokesperson said. (Turner, Modern Healthcare, 12/16)

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