We are back with a rundown of pertinent developments in the healthcare and pharma space, this week through a regulatory and market access lens. Some major happenings are: MHRA clinical trial legislation proposals, FDA domestic surveillance inspection starting back February 4, European Commission medical device regulation consultation and BMS joining the league of 340B discount restrictors.
Having left the European Union before the implementation of the Clinical Trials Regulation, the United Kingdom (UK) is charting its own course in clinical research. With the Medicines and Medical Devices Act 2021 providing powers to update the legislation, the Medicines and Healthcare products Regulatory Agency (MHRA) is now seeking feedback on how to use the recently gained regulatory freedoms. The MHRA is holding a consultation into the future of clinical trial legislation in the UK by seeking feedback on tens of proposals intended to streamline processes and remove unnecessary burdens to clinical trial sponsors. The proposals are grouped into 10 categories, such as: patient and public involvement, clinical trial approval processes and safety reporting. The sections feature multiple proposals and questions to gauge industry reception.
One MHRA idea is to require the involvement of “people with relevant lived experience in the design, management, conduct and dissemination” of clinical trials. Currently, Research Ethics Committees expect researchers to involve patients and the public in those processes, but there is no legislative mandate. As part of a wider effort to embed patient engagement in drug development, MHRA wants the legislation to require the involvement of people with relevant lived experience. Elsewhere, MHRA is seeking feedback on changes to the clinical trial approval process, including a move to a combined regulatory and ethics review and “a sponsor-driven timeline to respond to any requests for further information.” They propose to provide a time period of 60 days, but with flexible extension, for a sponsor to respond to any requests for information raised which would facilitate the harmonization of international protocols and better align requests for changes from multiple regulators.
Other proposals are intended to reduce the regulatory burden on lower-risk clinical trials. The MHRA plans to create a notification system for low-intervention trials that pose similar risks to standard medical care, thereby freeing them from the need for regulatory review. In regards to informed consent, the MHRA is considering changing the informed consent requirements for cluster trials that randomize patients to receive approved medicines. MHRA is questioning whether people should need to provide “written consent after being given detailed information about the trial in an interview with one of the investigators” to participate in such studies.
MHRA is accepting feedback on the proposals until 14 March. After the eight-week consultation, MHRA will review the responses and use them to inform decisions to finalize the drafting of the secondary legislation.
The US Food and Drug Administration’s (FDA) temporary pause on non-mission-critical domestic surveillance inspections ends February 4, 2022. The FDA previously announced it would halt certain inspectional activities amid the wave of COVID-19 infections driven by the omicron variant. The FDA has continued to conduct foreign and domestic mission-critical inspections, remote assessments and import operations surveillance. The agency had previously said it would postpone its planning of prioritized foreign surveillance inspections, which were scheduled to begin next month. They will proceed with previously planned foreign surveillance inspections that have received country clearance and are within the Center for Disease Control and Prevention’s Level 1 or Level 2 COVID-19 travel recommendation; otherwise, the inspection will be rescheduled.
Beginning March 1, 2022, BMS will recognize up to two designated 340B contract pharmacy locations per 340B hospital that lacks an entity owned pharmacy. A growing number of pharmaceutical companies have imposed restrictions on the use of 340B discounts purporting that the use of multiple contract pharmacies by hospitals and clinics leads to double billings, ineligible rebates, and other abuses. Earlier this month, the U.S. Department of Health and Human Services appealed several recent court rulings that questioned its approach to enforcing the decades-old initiative by threatening fines.
The European Commission is holding a public consultation about the application of the Medical Devices Regulation (MDR) to the safety of products with an aesthetic or non-medical purpose. MDR applies to products that have a similar function to medical products but are used for different aims, such as implants, dermal fillers and body sculpting equipment used in cosmetic surgery. The Commission has published the draft implementing regulation to set out its stance on risk management, clinical safety evaluation and other requirements related to the products. One part of the proposal sets out requirements that apply to all products. The Commission is proposing to give manufacturers of products already on the market three years from the date of application of the regulation to confirm their conformity with those general safety and performance requirements. Specific requirements for different types of devices are set out in a series of annexes. The Commission is accepting feedback until 11 February.