Content Detail

• Content META

  Title	Gauging the Likelihood of Trump Administration FDA Reforms
  ID	6129785
  External ID	7492735343
  Author	Avia Dunn, Maya Florence, Nicole Grimm, Rachel Turow
  Published Date	Jan. 23, 2025, 5:39 p.m.
  Summary	Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have f
  Tags	None
  URL	https://www.jdsupra.com/legalnews/gauging-the-likelihood-of-trump-3337099/
  Sentiment	Negative: 0.30727    Neutral: 0.64911    Positive: 0.04363
  Relevance	0.00000

• Content Details

  Content ID	3766766
  Key	43685541-4f98-4248-9a03-f5b3871d1598
  Content	Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from doctors, scientists, academics and researchers on what they think might change at the U.S. Food and Drug Administration (FDA) in a new administration. Many of these possibilities have been suggested before, and each has unique hurdles to implementation. Below we explore the likelihood that some of the more frequently discussed ideas will materialize and the realities of implementing them. 1. Eliminating User Fees Both RFK Jr. and President Trump have expressed desire to eliminate the FDA user fee programs. Many experts have also expressed concerns that user fees may make the agency more susceptible to industry influence and could lead to the approval of drugs or devices that are not supported by adequate scientific evidence. The solution, some suggest, is for Congress to fully fund FDA. Our Take Likelihood: Low. The first FDA user fee program, the Prescription Drug User Fee Act (PDUFA), was established in 1992 to combat significant backlogs and delays in drug approvals (specifically, the first antivirals to treat HIV/AIDS) due to limited resources at FDA. With more than 30 years of history now established, the user fee programs1 are a bedrock of FDA operations. PDUFA provides for negotiations between FDA and industry, which result in a public commitment letter that is discussed at a public meeting and then ratified by Congress. PDUFA fees are used to fund the programs and resources detailed in the commitment letter, including hiring more staff, to both enhance the efficiency of drug review and focus the FDA’s resources on innovative programs and research. Critics claim that user fees create a conflict of interest because FDA may perceive pressure to approve products when companies pay a user fee for review. However, FDA regularly has issued complete response letters for ( i.e., did not approve) applications submitted pursuant to user fees that it determined did not meet statutory and regulatory approval standards. More specifically, a recent analysis showed that as many as one-third of applications submitted in a fiscal year are not approved.2 Congress has reauthorized PDUFA multiple times, and user fees now comprise over half of FDA’s drug review budget. Eliminating user fees would require an act of Congress, and further require Congress to complete the appropriations process, which has not happened since 1997.3 Such a complete structural overhaul seems unlikely, although we may see reauthorizations of user fee programs delayed until the last minute, as occurred during the first Trump administration. 2. Closing the Revolving Door of Staff Members of the incoming Trump administration and outside experts have highlighted the number of employees who leave FDA to work in regulated industry and who join FDA from FDA-regulated companies. Some analysts have suggested this creates conflicts of interest, and others have suggested a cooling-off period during which FDA employees would not be able to oversee products they handled during previous employment. Our Take Likelihood: Low. FDA and industry both require highly skilled scientists and physicians to develop innovative products, and there are benefits to each group understanding how the other works. FDA maintains clear ethics policies that prohibit employees from participating “in any regulatory action before FDA that involves the former employer organization” for one year.4 FDA’s ethics rules also prohibit any FDA employee who previously worked at a regulated entity and holds any financial interest in that entity (for example, from stock options received during employment) from working on a matter related to their former employer.5 Separately, FDA makes public its approval and clearance packages for drugs and devices. These reports include the names of the FDA employees involved in the review. We believe that this transparency requirement further diminishes the likelihood of large-scale change in this area. 3. Making the 510(k) Process More Rigorous Critics of FDA’s medical device program have called for reforms to the 510(k) process, asserting a need for a more rigorous review of scientific evidence to support clearance of devices through this pathway. Our Take Likelihood: Low. Since the implementation of the Medical Device User Fee Amendments (MDUFA) in 2002, FDA’s Center for Devices and Radiological Health (CDRH) has substantially increased its oversight of Class II medical devices, including those that reach the market through the 510(k) pathway. Among other reforms, CDRH has implemented a total product life cycle (TPLC) approach, integrating safety and compliance into the initial review process, and has increased transparency of device recalls through an “early alert” system that notifies the public about significant issues that likely will lead to a recall.6 In addition, FDA reclassified many high-risk Class II devices as Class III following passage of the FDA Safety and Innovation Act in 2012.7 And, in 2023, FDA published three draft guidance documents narrowing the criteria for predicate selection, clarifying the appropriate use of clinical data and explaining evidentiary requirements for implants under 510(k).8 Further increasing the rigor of the 510(k) process would require substantially more resources due to the volume of 510(k) submissions FDA reviews each year. The most recent MDUFA performance report covering FY 2023 shows that FDA reviewed 3,222 510(k) applications requiring substantive interaction that year, in addition to 3,639 pre-submission packages. The 510(k) program is another review process agreed upon between FDA and industry via user fee negotiations. The commitments in the MDUFA letter outline how FDA administers the 510(k) program. Significant changes beyond those already implemented would require an act of Congress, which we believe is unlikely to be a priority given the numerous medical device oversight reforms that have occurred over the past decade. 4. Creating a Separate Agency for Food RFK Jr. has brought renewed focus to FDA’s regulation of food while pundits have called for separation of the agency into two agencies: one focused on medical products and one focused on food.9 This could bring more attention and resources to FDA’s new Human Foods Program, which some analysts assert is often overshadowed by the medical products programs. Experts also note that the regulatory regime for foods is very different than that for drugs and devices and that FDA currently approaches food regulation primarily through enforcement, with little opportunity for premarket review. Proponents of a separate food agency believe that more premarket review, especially for food additives, is warranted. Our Take Likelihood: Moderate Food and nutrition policy are an avowed priority for RFK Jr., and many of his stated goals could be more easily achieved if there were a separate, better-resourced agency regulating food that was able to engage in more premarket review. However, creating a new agency for food would require Congress to disentangle food from the Federal Food, Drug, and Cosmetic Act — which gives FDA its current authority to regulate food — and create a new statutory authority for food along with a new agency. Such a Herculean task would need to be a singular focus for the new administration and would require setting aside major priorities in other areas FDA regulates. While there may be support for this reform at the top levels of HHS if RFK Jr. is confirmed, Congress seems unlikely to come together to the degree required to make this happen. Also, the idea of establishing a new federal agency may run counter to the goals of the new Department of Government Efficiency and could meet further roadblocks there. 5. Overhauling the GRAS Process for Food Additives Experts have raised concerns about the GRAS (Generally Recognized As Safe) designation for food. Many experts view the GRAS designation process as a loophole that allows food additives to reach the market without premarket review and permits substances designated as GRAS to be used in dietary supplements once they have become part of the food supply. These experts have called for a new process to review GRAS substances and food additives, both those that are on the market and those that are coming to market. Our Take Likelihood: Moderate An overhaul of GRAS would align with RFK Jr.’s expressed priorities regarding ultra-processed foods. However, FDA previously undertook a 30-year comprehensive review of all GRAS food substances and, in 1997, concluded that the FDA could not sustain the review due to time and resource constraints. The asserted need for reform of the GRAS designation highlights that the GRAS system creates a process of elimination rather than one of affirmative regulation. Under the GRAS system, companies are responsible for (i) determining whether a substance is GRAS or, instead, requires submission to the FDA as a food additive, and (ii) undertaking their own processes to establish GRAS status for new substances. However, claims that the current system does not entail FDA oversight of products deemed GRAS are not accurate: If a manufacturer fails to perform the scientific review required to establish a substance as GRAS or does not submit a non-GRAS substance to FDA for review as a food additive, then the substance is considered an unlawful food additive and FDA can take enforcement action.10 Moreover, a switch from the current GRAS process to one requiring premarket review of most food ingredients — rather than the small minority currently subject to premarket review — would likely overwhelm FDA’s resources, similar to what occurred during FDA’s previous, 30-year review of GRAS food substances. While we therefore do not expect elimination of the GRAS designation, we may see the new Trump administration take steps to narrow FDA’s criteria for what constitutes adequate evidence of GRAS, which would result in directing more substances into the review pathway for food additives. As with the other proposed reforms, this expanded review pipeline would require additional resources for FDA, which lowers the likelihood that the reform will occur. 6. Increasing Focus on Dietary Supplement Safety Public health experts who study dietary supplements have flagged an increase in dangerous and adulterated supplements and in supplements that are misbranded, mislabeled or make unsubstantiated medical claims. Experts also emphasize that many of these products are being imported unchecked from outside the U.S. These experts believe that FDA’s efforts to curtail bad actors in the dietary supplement pipeline are insufficient given the asserted magnitude of the problem and risk to consumers. Our Take Likelihood: High FDA recently reorganized its food program under a deputy commissioner of the FDA’s Human Foods Program, Jim Jones, and dietary supplements are now housed in the new Office of Food Chemical Safety, Dietary Supplements & Innovation. Under current FDA requirements, dietary supplements are regulated similarly to how GRAS substances are regulated in that manufacturers are only required to notify FDA if their dietary supplements contain a new dietary ingredient or make certain structure/function claims on which the manufacturer would like FDA’s advice. Neither of these processes is a barrier to market. FDA has repeatedly asked Congress for dietary supplement registration and listing authority,11 and lawmakers introduced legislation to give FDA that authority.12 In addition, retailers have begun requiring dietary supplement manufacturers to have their products tested by third-party laboratories prior to listing the products for sale.13 The industry also is creating initiatives on its own to combat adulterated dietary supplements and fraud from foreign entities. Of the reforms we have seen, experts suggest increased regulation of dietary supplements may be the most likely to come to fruition as a priority for the new Trump administration. Other Proposals While we have not seen these proposals mentioned by academic experts, RFK Jr. has floated a number of other proposals for FDA reform that have received significant press. These include: Eliminating direct-to-consumer advertising for pharmaceuticals. We believe the likelihood of this gaining traction within FDA or through congressional action is low. FDA has repeatedly lost in court on First Amendment grounds when trying to regulate pharmaceutical advertising,14 and industry opposition to any FDA attempt to curtail speech would likely be widespread. Given these headwinds, we do not expect Congress to prioritize this issue in the new term. Withdrawing or limiting use of vaccines. This issue, more than most, will test the relationship between a nonscientist HHS secretary and a clinician FDA commissioner (assuming both RFK Jr. and Dr. Marty Makary are confirmed). Withdrawing approval of particular vaccines involves a long administrative process that requires hearings for the relevant manufacturer, and the matter would likely end up in court. Therefore the likelihood of a vaccine approval withdrawal is low. However, FDA has several policy tools available to explore the use of vaccines, including public meetings, opening a public docket, convening an advisory committee meeting or issuing guidance on vaccine use. FDA would most likely use these policy tools to gain stakeholder feedback before pursuing formal action. Making directors at the FDA center political appointees. After the surprise retirement of Patrizia Cavazzoni, the incoming FDA commissioner will be able to choose the next director of the Center for Drug Evaluation and Research. This could create an opportunity to convert the FDA center director roles from career civil servants to political appointees, which would align with other policy objectives announced by the Trump administration. The executive order signed on January 20, 2025, announcing that members of the career Senior Executive Service serve at the pleasure of the president may be the first step in making these roles less permanent. _______________ 1 FDA now has user fee programs for branded prescription drugs (PDUFA), OTC monograph drugs (OMUFA), generic drugs (GDUFA), biosimilars (BsUFA), medical devices (MDUFA), animal drugs (ADUFA) and animal generic drugs (AGDUFA). 2 Citeline, “ US FDA’s Use Of CRLs Hit A High Note In 2022: One-Third Of Novel Agent Decisions Were Not Approvals
  Content Reference URL	None

• Publisher

  Publisher Name	JDSupra (#3988)
  Publisher URL	https://www.jdsupra.com/
  Description	None
  Trust Flow Score	59
  Citation Flow Score	53

• Data Source

  Data Source Name	Quantexa News (#5)
  Data Source Type	news
  Data Source URL	https://app.aylien.com/dashboard
  Description	Welcome to Quantexa News API — the most powerful way to aggregate, filter, and integrate global news data into your apps and models.
  Weight	10