Following reports of shortages of several drugs needed to treat patients with COVID-19 infections, the U.S. Drug Enforcement Administration (DEA) announced this week that it is increasing its aggregate production quotas for certain controlled substances identified by the Department of Health and Human Services as impacted by the pandemic. The agency issued a final order increasing the 2020 quotas by 15% for fentanyl, morphine, hydromorphone, codeine, ephedrine and pseudoephedrine, as well as controlled substance intermediates that are essential to the production of those schedule II drugs. The DEA also will increase the quota for methadone to ensure that opioid treatment programs have sufficient supplies to treat patients. In addition, the agency is increasing the authorized amounts of certain schedule III and IV controlled substances that may be imported into the U.S. to treat patients on ventilators. These drugs include ketamine, diazepam, midazolam, lorazepam and phenobarbital. Higher quotas will allow manufacturers to ramp up production of the controlled substances to meet the increased demand. The DEA said it will reevaluate the demand and adjust the quotas as needed once the pandemic recedes.
Real world data is coming into its own as drug regulators from more than two dozen countries recognized how data generated during clinical practice could complement evidence from clinical trials testing potential therapeutics or vaccines against COVID-19. During a workshop on the coronavirus, the International Coalition of Medicines Regulatory Authorities acknowledged “the importance of observational studies of real world data for increasing the effectiveness and efficiency of regulatory processes and decision-making in the development, authorization and monitoring of medicines and vaccines to prevent and treat COVID-19 and to address knowledge gaps that cannot be addressed by clinical trials,” according to the EMA, which organized the workshop.
Responding to public demand for more information on prescription drugs under evaluation, Australia’s Therapeutic Goods Administration (TGA) will be implementing enhanced transparency measures. Beginning in June 2020, the TGA will provide earlier publication of information on the potential availability of new drugs, or new uses for medicines and new combinations that include at least one new drug as an active ingredient. As of early 2021, the TGA plans to give innovators earlier notification of generic applications. Meanwhile, the agency is seeking feedback from sponsors on ways to implement the two measures. Comments should be submitted by June 9, 2020.
The U.S. Court of Appeals for the Federal Circuit Wednesday reinstated Mylan NV’s challenge to Valeant Pharmaceuticals International Inc.’s ’025 patent, which claims stable methylnaltrexone pharmaceutical preparations. The patent, which expires in April 2024, is listed in the FDA’s Orange Book for Relistor, an injectable drug used to treat constipation as a side effect of taking an opioid. After Mylan, of Hertfordshire, U.K., filed an abbreviated new drug application with the FDA to market a generic version of Relistor, Valeant sued for infringement. (The Laval, Quebec-based Valeant has since changed its name to Bausch Health Companies Inc.) Mylan then sought to invalidate the patent based on obviousness. The Federal Circuit said a lower court was wrong in granting Valeant summary judgment, given Mylan’s obviousness arguments. Mylan’s appeal raised the question of “whether prior art ranges for solutions of structurally and functionally similar compounds that overlap with a claimed range can establish a prima facie case of obviousness. We conclude that they can and, in this case, do,” the appellate court said, adding that the district court erred when it rejected that inference as a matter of law at the summary judgment stage. The Federal Circuit also found fault with the lower court’s obvious-to-try analysis, saying it was inconsistent with precedent. “There is no requirement that for a variable to be obvious to try, it must be the first variable a person of skill would alter,” the Federal Circuit said.