In the same breath that the Drug Enforcement Administration (DEA) claimed it's moving forward to facilitate and expand scientific and medical research for marijuana in the U.S., the agency said this week that decisions on pending applications from entities seeking to be registered to manufacture marijuana for that research will have to wait until the agency proposes new regulations to govern a growers program. The new rules are needed to ensure the DEA "can evaluate the applications under the applicable legal standard and conform the program to relevant laws," according to the agency. While the DEA provided no timeline for proposing the rules and kicking off what typically is a lengthy rulemaking process, it continues to take registration applications. Meanwhile, the number of individuals registered with the DEA to conduct research with marijuana, marijuana extracts, derivatives and delta-9-tetrahydrocannabinol (THC) increased by more than 40% over the past two years – from 384 in January 2017 to 542 in January 2019. The agency acknowledged that registering additional qualified marijuana growers would increase the variety of marijuana available for research.
U.S. Surgeon General Jerome Adams issued an advisory Thursday emphasizing the health risks of marijuana use in young people and pregnant women. "There is a false perception that marijuana is not as harmful as other drugs. I want to be very clear – no amount of marijuana use during pregnancy or adolescence is known to be safe," Adams said. THC, a component of marijuana, binds to receptors in the brain, producing potentially harmful effects, including intoxication and memory and motor impairments. The advisory noted a surge in products with more potent THC concentrations that lead to risks like anxiety, agitation, paranoia and psychosis.
Concerned that patients with a legitimate need for opioid pain relief are being denied access to the drugs, Sen. Bill Cassidy (R-La.) is delving into misunderstandings between U.S. doctors and regulatory agencies such as the DEA about best practices in prescribing opioids. In a letter Wednesday to DEA Active Administrator Uttam Dhillon, the senator asked several questions about the DEA's opioid prescribing instructions to doctors and pharmacies. He also questioned whether the agency is following the recommendations in the Health and Human Services (HHS) Pain Management Best Practices Inter-Agency Task Force Report that was issued in May. The report emphasized the distinction between patients being treated for chronic pain who are on a stable dose of opioids and under the continuing care of a doctor and those with opioid use disorder who exhibit drug-seeking behaviors. Cassidy urged the DEA to use the best practices report as a tool to better equip doctors caring for patients with acute, chronic pain.
The Centers for Medicare & Medicaid Services (CMS) must do more to avoid paying twice for the same drugs, the HHS Office of Inspector General (OIG) said this week after finding that the agency continues to pay millions more for prescription drugs under Medicare Part D that are covered by the Part A hospice benefit. As it has in the past, OIG recommended that CMS work directly with hospices to ensure they provide drugs covered under the hospice benefit. The OIG report also advised CMS to develop and implement a strategy to ensure that Part D does not pay for drugs covered by the hospice benefit. That recommendation could save at least $160.8 million a year in Part D costs, "with potentially much higher annual savings associated with the drugs that hospices said they were not responsible for providing," OIG said. Such a strategy would involve CMS working with Part D sponsors and seeking additional authorities that may be necessary to develop proper controls.
In a precedential ruling revolving around the interpretation of "wherein" clauses in three Allergan plc patents, the U.S. Court of Appeals for the Federal Circuit Thursday sided with a lower court that issued a preliminary injunction against Sandoz Inc.'s generic version of Allergan's eye drug Combigan (brimonidine/timolol). The district court found that the "wherein" clauses were limiting because they were material to patentability and expressed the inventive aspect of the invention – Combigan's ability to reduce administrations from three times daily to twice daily without a loss of efficacy and with fewer adverse events. Sandoz disputed that interpretation, arguing that the clauses merely reflected Combigan trial results and that the recited results were not material to patentability. The Federal Circuit disagreed, saying that while there was some overlap between the language of the clauses and the trial results, the claims had to be read in view of the entire specification. "The claimed invention is ultimately a formulation (and methods of using that formulation) that allows for increased efficacy and safety," the appellate court said. It also noted that the prosecution history of the claims showed that both Allergan and the patent examiner expressly relied on the formulation's efficacy and safety, as reflected in the "wherein" clauses, to define the claimed methods and distinguish them from the prior art. "The 'wherein' clauses were neither unnecessary nor irrelevant, but were instead material to the examiner's patentability determination," the Federal Circuit said.