Saying a letter isn’t a final action under the Administrative Procedure Act (APA) doesn’t make it so, the U.S Court of Appeals for the District of Columbia Circuit ruled Tuesday when it remanded Ipsen Biopharmaceuticals Inc.’s suit against the Department of Health and Human Services (HHS) to a federal district court. The lower court had originally dismissed the case, granting HHS’ request for summary judgment based on the Centers for Medicare & Medicaid Services’ (CMS) claim that it had taken no final action that could trigger judicial review under the APA. At issue in the lawsuit is correspondence between Ipsen, part of Paris-based Ipsen SA, and CMS over a disagreement about the baseline pricing data for calculating the inflationary Medicaid rebate for Ipsen’s hormone-lowering drug, Somatuline (lanreotide) ED, approved by the FDA in 2014. Ipsen claimed the 2014 date as the baseline for the rebate, since that’s when the outpatient formulation of the drug came on the market. CMS notified the company that the baseline data must be changed to reflect the original baseline data of the Somatuline Depot injection, which came to market in 2007. Ipsen responded and asked for a meeting. CMS’ director of the Division of Pharmacy replied, repeating the agency’s view that a new base date average manufacturer price was not warranted because Somatuline ED was approved under a supplemental new drug application based on the new drug application for Somatuline Depot. Although the director’s letter stated that it was not “a final agency action or even an initial determination on a reimbursement claim,” the appellate court said the letter was, indeed, a final action subject to judicial review because it was “an action by which rights or obligations have been determined, or from which legal consequences will flow.” Agreeing with Ipsen, the appeals court said the letter “significantly increased [Ipsen’s] risk of a statutory civil penalty being levied for ‘knowingly provid[ing] false information,’” adding that the increased risk is a “legal consequence” sufficient to make the agency action final.
The National Academies of Sciences, Engineering and Medicine is calling on the FDA to strengthen cooperation with regulators in other countries to ensure the quality, safety and efficacy of medicines. “No regulator has all the human and technical resources it needs to meet all of its public health responsibilities, especially as their workloads increase due to the growing complexity of medicines, societal expectations for faster drug approvals and the rising demand for inspections of manufacturing facilities overseas,” the academies said in releasing a recent report, Regulating medicines in a globalized world: The need for increased reliance among regulators. The report includes recommendations to promote information sharing among regulators globally with the aim of protecting public health, ensuring faster access to critical medicines and encouraging innovation. Given that drugs are global commodities, the regulation of medicines should function as seamlessly as industries such as banking and telecommunication that operate across borders, said Alistair Wood, chair of the committee that wrote the report.
Due to the ongoing shortage of Mylan NV’s Epipen Jr. (epinephrine), Australia’s Therapeutic Goods Administration (TGA) said it will allow distribution of one batch of the autoinjectors that has not met all the required quality specifications. The shortage, which is expected to continue until Jan. 31, resulted when several batches of the autoinjector, used in emergencies to reverse life-threatening allergic reactions, were found to be contaminated with low levels of pralidoxime, a drug used to treat people poisoned by pest-control chemicals. “The risk from not having adrenaline [epinephrine] available to treat anaphylaxis is far greater than the risk of being exposed to a very small amount of pralidoxime,” the TGA said.
HHS Tuesday launched Ready, Set, PrEP, a national program that makes drugs for pre-exposure prophylaxis (PrEP), taken daily to prevent HIV, available at no cost to people in the U.S. without prescription drug insurance coverage. The program is part of the administration’s Ending the HIV Epidemic initiative, which aims to reduce the number of new HIV infections in the U.S. by 75% in five years and by 90% in 10 years. Earlier this year, Gilead Sciences Inc., of Foster City, Calif., announced it would donate up to 2.4 million bottles of Truvada (emtricitabine/tenofovir disoproxil fumarate) annually to HHS’ Centers for Disease Control and Prevention for uninsured Americans at risk for HIV. The annual donation was to extend to 2030, with plans for it to transition to Descovy (emtricitabine/tenofovir alafenamide), which was approved in October for PrEP. In its announcement of the Ready, Set, PrEP program, HHS noted several pharmacy chains would be providing their dispensing services for free, but it made no mention of the Gilead PrEP drug donation. HHS filed suit against Gilead last month, claiming the company was infringing government patents related to the PrEP use of Truvada and Descovy. Meanwhile, Gilead is challenging the validity of the government patents through inter partes review.