The FDA today unveiled its latest budget request featuring eight new requests for legal authority related to the regulation of medical products, including new authority over accelerated approvals, generic drug approvals, and remote inspections. AgencyIQ has a breakdown of what FDA has requested and to what extent Congress is ready to take action.
- As part of the annual budget process, each executive agency makes a budget request of Congress. In addition to funding, these requests also include requests for additional legislative authority. While these requests are rarely granted in full, FDA often finds Congress willing to grant some of its requests, either as part of the budget process or long-term as part of other reform measures.
- As part of its FY2023 budget request, the FDA has asked Congress for new authority in 14 areas, including many related to medical products. The requests include those related to accelerated approvals, generic drug approvals, medical device cybersecurity, drug and device shortage mitigation, dietary supplement oversight, and the destruction of imported products that are deemed to pose a significant risk to public health. Notably, several of these proposals have already been adopted by legislators in recently proposed legislation.
- Generic drug provisions: FDA is asking Congress to make changes to the generic drug approval system. At present, companies that are first-to-file a generic drug application are granted 180 days of marketing exclusivity, during which other generic drug products may not be marketed. However, in practice the first product is often “parked,” meaning that other generic drug entrants cannot be marketed before the first generic is placed on the market, or the first-to-file company takes a long period of time to obtain approval. This can limit generic competition. To solve this, the FDA has said it wants to amend the 180-day exclusivity provisions “to specify that FDA can approve subsequent applications unless a first applicant begins commercial marketing of the drug, at which point approval of subsequent applications would be blocked by 180 days, ensuring that the exclusivity actually lasts 180 days […] rather than for multiple years.” Notably, this issue has already received attention from legislators, such as the Expanding Access to Low-Cost Generics Act of 2021 sponsored by Sens. Mike Braun (R-IN) and Tina Smith (D-MN).
- Accelerated approval: FDA has asked Congress with help to accelerate the process of removing products from that market in instances where the drugs’ respective confirmatory studies “progress too slowly.” The agency has cited this as an issue in recent years, and has begun an effort deemed “ Project Confirm” intended to monitor oncology products whose confirmatory studies are overdue. According to the justification, FDA wants additional legal authority to expedite the process of removing these products from the market. Specifically, it wants the authority to include a condition of approval “that a drug sponsor must first demonstrate that a proposed post-approval (i.e., confirmatory) study is adequately designed to verify and describe clinical benefit and can be completed in a timely manner.” FDA also wants the authority to remove products that do not complete their confirmatory studies from the market. These reforms are similar to those proposed by Rep. Frank Pallone as part of his Accelerated Approval Integrity Act of 2022.
- Remote evaluations: In 2012, the FDA received critical authority under the FDA Safety and Innovation Act (FDASIA) to request records from manufacturing facilities “in advance or in lieu of drug inspections.” The FDA has leveraged this authority in some novel ways since then, including using the authority as the basis of its drug quality metrics proposal and – critically during the pandemic – its remote inspections program. However, there’s a critical gap: “FDA’s authority to conduct remote regulatory assessments is limited to requests for records and other information in advance or in lieu of drug inspections and FDA currently lacks authority to require any establishment to participate in remote interactive evaluations” according to the agency. To fill this gap, it wants to be able to compel companies to participate in these “remote interactive evaluations” (FDA doesn’t consider them to be the same as inspections, and therefore uses this alternative phrasing), and also to provide records upon FDA’s request. This authority would notable expand FDA’s authority in this area over all FDA-regulated product, including medical devices and bioresearch monitoring inspections (BIMO). It would also give FDA the authority to make use of livestreaming, teleconferences and screen sharing. FDA’s request would be partially met by legislation now moving through Congress known as the PREVENT Pandemics Act, which contains provisions related to medical device remote inspections.
- Destroying certain imported products: Combatting the counterfeiting of medical products is a constant cat-and-mouse game – one the U.S. government plays with extensive and evolving regulatory and statutory authorities. For example, in recent years the FDA has obtained the authority to destroy certain counterfeit medical devices they discover rather than return them to their point of origin. In its budget request, FDA says it now wants to expand this authority to defer its costs of destruction. According to the FDA: “Under current practice, when [Customs and Border Patrol] CBP seizes an FDA-regulated product, an FDA violation is used to support the seizure. CBP then consults with FDA to confirm that the product seized violates the FD&C or PHS Acts and/or FDA regulations. Additionally, if the seizure is successful, the government will likely end up paying for the destruction.” But under the new authority FDA is seeking, FDA would be able to order the destruction (rather than CBP) and require the “importer of record” to pay for the destruction “up front,” which would reduce FDA’s costs of destruction and legal costs.
- Medical device cybersecurity: The FDA typically regulates products based on three core factors: Its safety, its efficacy, and its quality. But for medical devices, there is a fourth consideration: Its security. Specifically, the cybersecurity of a product and its resilience to unauthorized access can have a substantial impact on device quality, safety and efficacy. Traditionally the FDA has asked companies to submit information about the cybersecurity of medical devices as part of the pre-market submission process. However, as noted by the FDA, there is currently no statutory requirement that device companies address cybersecurity concerns either prior to or subsequent to a market access decision by the FDA. The FDA says it now wants this authority explicitly. It also wants the authority to require companies to demonstrate “reasonable assurance” of the device’s cybersecurity, require that companies patch or update known risks in a “timely manner,” require sponsors to provide a “software bill of materials” for marketed devices containing a list of all software components used (such as specific operating systems), and publicly disclose when manufactures are made aware of specific cybersecurity risks. Notably, legislation to this effect (the Protecting and Transforming Cyber Health Care (PATCH) Act) was recently introduced in the House by Representative Michael Burgess.
- Medical device shortages: Until the start of the pandemic and the passage of the CARES Act in 2020, the FDA did not have the authority to compel medical device manufacturers to notify it of pending shortages. Even now, it only has partial authority over shortage notifications. The FDA has frequently asked Congress for additional authority over device shortages, and this budget request contains yet another. Specifically, the FDA wants the authority to compel companies to notify it of any time there is a potential for a shortage (rather than an active one), require companies to conduct risk assessments of their supply chains and implement risk management plans, permit FDA to temporarily approve the importation of unapproved devices (with “appropriate scientific and regulatory controls”) during shortages, and authorize that devices be able to be distributed past their labeled shelf life. Notably, this authority would be similar to language included in the PREVENT Pandemics Act.
- Dietary supplements: The FDA has long asked for additional oversight authority over dietary supplements with respect to safety. In its current budget request, the FDA has asked for additional authority to compel product manufacturers to list their products each year with the FDA, and to also have the authority to “facilitate enforcement against unlawfully marketed products.” At present, the FDA often needs to compel market removals through legal orders. While the FDA doesn’t specify the exact authority it’s seeking here (compared to some other sections of its request, where it quotes the exact language it wants added or changed), several major trade groups support the FDA’s efforts with respect to mandatory product listing, including the Council for Responsible Nutrition and the Consumer Healthcare Products Association (CHPA).
- Extending drug expiration dates: Finally, FDA’s budget requests asks for the authority to extend certain drug expiration dates when such expirations are intended to “mitigate critical drug shortages.” The provision would require companies to, when required, submit study data supporting the “longest possible expiration date (shelf-life) that FDA agrees is scientifically justified,” with civil monetary penalties for companies that fail to comply. Similar language is also contained within Section 512 of the PREVENT Pandemics Act.
To contact the author of this piece, please email Alec Gaffney ([email protected])