Citing the COVID-19 pandemic, Canada is once again delaying the implementation of amendments to its Patented Medicines Regulations. Those amendments include additional price regulatory factors the Patented Medicine Prices Review Board (PMRB) must consider when determining whether the price of a patented medicine is excessive, an updated schedule of comparator countries for pricing purposes and changes in price reporting requirements. The changes originally were supposed to become effective last July, but that date was pushed back to Jan. 1 as the first wave of COVID-19 hit Canada. Now the in-force date for most of the changes is being delayed until July 1, 2021, to give manufacturers more time to make necessary adjustments to comply with the new rules. The amendment that allows the PMPRB to collect price information net of third-party rebates is being indefinitely postponed, according to a notice published in the Jan. 20 Canada Gazette.
The U.S. FDA issued new guidance with risk-based recommendations for manufacturers of licensed and investigational cellular and gene therapy (CGT) products to minimize potential transmission of the SARS-CoV-2 coronavirus. Intended as a supplement to the agency’s June 2020 guidance, “Good manufacturing practice considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing,” the recommendations in the new guidance address the source material recovered from donors and how the CGT product will be manufactured. The guidance applies to CGT products regulated by the Center for Biologics Evaluation and Research under section 351(i) of the Public Health Service (PHS) Act and as drugs under section 505 of the Federal Food, Drug and Cosmetic Act (FDCA). It doesn’t apply to human cells, tissues and cellular- or tissue-based products regulated solely under section 361 of the PHS Act or regulated as medical devices under the FDCA.
Canada is investing $6 million in the Canadian Network of COVID-19 Clinical Trials Network to further coordinate research on tools to prevent, detect, manage and treat COVID-19. Led by Robert Fowler from Toronto’s Sunnybrook Research Institute, the network will use public feedback to help set research priorities. It also will facilitate collaboration and resource sharing, reduce duplication of efforts and harmonize clinical trial procedures.
A declaratory ruling last week by the U.S. Federal Communications Commission (FCC) could make it easier for drug companies to recruit for clinical trials. In response to Horsham Township, Pa.-based Acurian Inc.’s petition for a ruling, the FCC said prerecorded voice message calls to residential phone lines seeking participation in a clinical trial are exempt from the Telephone Consumer Protection Act’s prior-express-written-consent requirement – so long as the calls do not include advertising or telemarketing messages. However, in keeping with FCC rules, the caller is limited to no more than three such calls, within a 30-day period, to a phone number and must provide an opt out of future calls.
The U.S. Centers for Medicare & Medicaid Services is seeking applications for its calendar year 2022 Part D Payment Modernization Model. The model is open to eligible standalone prescription drug plans and Medicare Advantage prescription drug plans. New features for the 2022 model include flexibility for participating plan sponsors to treat five of the six protected drug classes – anticonvulsants, immunosuppressants, antidepressants, antipsychotics and antineoplastics – as they would other Part D drug classes, meaning they wouldn’t have to cover all drugs in those classes. The model also will allow participating sponsors to include just one drug per class instead of the current requirement for two drugs per class. The goal is to reduce beneficiary out-of-pocket costs and overall Part D prescription drug spending.