A Look Ahead in Life Sciences: What We Are Tracking in Q1 2023 and Beyond

How companies develop their products: 

• We are anticipating final FDA regulations that would harmonize clinical research regulations with the HHS Common Rule. (US) 
• We are assessing FDA’s recently issued draft guidance addressing ethical considerations for research involving children and monitoring a new bill introduced in Congress that would address inclusion of pregnant and lactating women in clinical research. (US)  
• We expect FDA to implement its new clinical trial Diversity Action Plan authority for Phase 3 drug and biologic developers and device developers conducting clinical trials (whether under IDEs or not), as embedded in section 3601 of the Food and Drug Omnibus Reform Act (FDORA). (US)
• We also expect forthcoming guidance from FDA regarding additional authorities granted under FDORA regarding decentralized clinical trials, use of digital technologies in trials, modernizing clinical trials, and more. (US) 
• We expect to see the continued use of bioresearch monitoring (BIMO) regulatory assessments. (US) 
• EMA GCP Q&A Update issued December 2022 for sponsor oversight of activities delegated by contract. (EU)   
• We will be watching FDA’s implementation of a new provision of the FDCA that allows FDA to designate a “platform technology” that has the potential to be incorporated in or utilized by more than one drug. Under section 2503 of the FDORA, FDA may expedite the development and review of a subsequent application for a drug that incorporates or utilizes a designated platform technology. (US) 

Deciding whether a company can market or sell a specific product: 

Pharmaceuticals/Biologics 

• We will continue to see the use of real-world evidence in submissions, including likely continued guidance from FDA. Section 3629 of the FDORA requires FDA to issue and/or update its guidance within one year. (US) 

Medical Device/Medtech 

• We are continuing to monitor how the recent FDA Guidance on Clinical Decision Support Software is being applied by the agency. (US)
• We are monitoring FDA’s Total Product Life Cycle Pilot designed to help reduce time from concept to commercialization for medical devices going through the FDA approval/clearance process. (US)
• We anticipate implementation of new cybersecurity authorities for software-containing or internet-connected devices, enabling FDA to require sponsors to develop cybersecurity plans for post-market implementation, as mandated in section 3305 of FDORA. We also anticipate final guidance from FDA relating to quality system and premarket submission considerations to address cybersecurity in medical devices. (US)
• We expect FDA to implement its new authority from section 3308 of FDORA regarding predetermined change control plans (PCCPs) for digitally enabled devices where subsequent changes do not require new premarket applications. (US)
• We also anticipate final FDA guidance on the content of premarket submissions for device software functions. (US) 

In Vitro Diagnostic/Laboratory Testing

• We expect forthcoming guidance from FDA on medical devices that fall within enforcement policies and Emergency Use Authorizations (EUAs) issued during the COVID-19 Public Health Emergency. (US)
• Note: The Omnibus Spending Law did not include the VALID Act, covering FDA regulation of laboratory developed tests (LDTs). (US) 

Notable Regulatory Approval Updates Outside the United States 

• We highlight the January 2023 formal proposed regulation issued by the European Parliament and Council extending the Medical Device Regulation implementation period, slated for acceptance in early 2023. (EU)
• We expect to see and plan to follow an early 2023 EU pilot program implementation for expert panel assistance to orphan and breakthrough device manufacturers. (EU) 

How companies manufacture, promote, and monitor their approved products: 

• FDA’s quality management system regulations with ISO 13485. (US)   
• We will see FDA implement its newly expanded authority under section 2511 of FDORA for registration of foreign manufacturers contributing to products, such as those performing processing steps, producing ingredients or components, to register with FDA. (US)
• Section 3611 of FDORA expands FDA’s authority over medical device inspections to allow FDA to collect “records or other information” from facilities “in advance of, or in lieu of” inspections of manufacturing establishments. We will be monitoring for FDA’s guidance on this new authority. (US) 

Whether Medicare/Medicaid or commercial payors are willing to pay for a product, how much, and under what circumstances: 

• Section 3630 of FDORA codifies FDA’s previous guidance that permits pre-approval communication to payors and formulary committees about healthcare economics information related to unapproved products or unapproved uses of products. (US) 

Pharmaceuticals/Biologics 

• We continue to follow how the Inflation Reduction Act of 2022 will impact reimbursement for pharmaceutical and biologic products (price caps, required discount program for all drugs, mandatory rebates if a drug’s price increases at a rate that outpaces inflation, and a redesign of the Medicare Part D benefit). We anticipate program instructions from CMS with respect to price caps for expensive single-source drugs and biologics in 2023. Some companies have already announced making pipeline changes based on the IRA’s effects. (US)
• HHS has issued a new proposed rule that would modify the current alternative dispute resolution process under the 340B drug discount program, which has been the subject of much scrutiny and disagreement among pharmaceutical manufacturers (who are obligated to cap prices significantly for patients of qualified covered 340B public health entities) and the public health entities whose patients benefit from reduced 340B pricing. The proposed rule which is open for comments until Jan. 30, 2023 would simplify and expedite the process by which covered entities and drug manufacturers resolve disputes about overcharging, duplicate discounts, or drug diversion. (US) 

Medical Device/Medtech 

• FDA’s Center for Devices & Radiological Health launched its Payor Communication Task Force to facilitate medical device manufacturer discussions with payors and to potentially shorten the time between FDA approval or clearance and coverage decisions. (US)
• On the horizon (anticipated April 2023) – new Medicare regulations to address the medtech “Valley of Death” and permit earlier coverage of breakthrough technology: Transitional Coverage of Emerging Technology. (US)
• Following: Whether Congress will re-introduce the Access to Prescription Digital Therapeutics Act, which in 2022 marked a first effort to develop a Medicare benefit for prescription digital therapeutics. (US) 

Companies’ interactions with sensitive patient data: 

• We continue to see increasing touchpoints for companies accessing sensitive patient information through integrated data platforms that could more significantly implicate HIPAA. (US)