Doctors for America Supports FDA Funding in Approps

May 22, 2024

Dear Chair Murray, Ranking Member Collins, Chair Cole, and Ranking Member DeLauro,

We write to urge your support for robust funding for the U.S. Food and Drug Administration (FDA) for FY25. As an organization of independent physicians and medical trainees across the country, we strongly believe that an increase in the FDA’s FY25 budget is necessary to enable the agency to carry out its core functions of protecting public health and enabling timely access to truly safe and effective medical products effectively.

As physicians, we rely on the FDA’s scientific expertise and efficiency when we treat patients. Any decrease or renewal of flat funding could result in a catastrophic decline in the agency’s efforts to protect public health and could hinder access to lifesaving medical products for patients. We’d especially like to call to your attention a few issues that we believe FDA would be better equipped to handle with sufficient appropriations.

Clinical Trial Transparency

Recently, the Universities Allied for Essential Medicines (UAEM), the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), and Columbia Law School’s Science, Health and Information Clinic (SHIC) released, “Transforming Clinical Trial Results Reporting in the United States.” The report outlines the need for greater enforcement of clinical trial result reporting by the FDA and National Institutes of Health (NIH) as required by law. The FDA has the power to protect patients and ensure that therapeutic approvals are safe, but it must uphold its mandate to oversee the testing of promising drugs and devices and ensure timely public availability of clinical trial results.

The report found that:

  • When used, Notices of Noncompliance that set a time limit for compliance with penalties including daily fines and criminal action are 100% effective; however, the prior step of issuing Pre-Notices or warning letters are also remarkably effective at 90% in improving results reporting.
  • There are thousands of non-compliant clinical trials, yet the FDA has only issued 149 Pre-Notices where the agency announces that in 30 days they will undertake an investigation of suspected noncompliance, despite how effective the notices are.
  • There is widespread noncompliance with results information reporting requirements. FDA and NIH are aware of this issue, as up until 2023, they had been required to send reports documenting how many trials had missing results information to the Senate Health, Education, Labor, and Pensions and House Energy and Commerce Committees.

Ensuring that data and clinical trial information are complete and compliant is imperative to protect patient safety and provide clinicians with sufficient information to make informed prescribing decisions. The FDA should be armed with the funding it needs to enforce compliance. Though the FDA has not requested additional Congressional appropriations or user fees dedicated to enforcement, we as physicians are asking Congress to ensure funds are adequately appropriated to ensure compliance. In response to a Citizen Petition urging them to increase their enforcement efforts, the FDA stated that they relied on “voluntary compliance” from trial sponsors and the agency had limited compliance resources, making it difficult to increase their enforcement capabilities despite the incredible backlog of trials with missing results information. This lack of oversight is a safety and an economic issue; if the FDA had fully wielded its authority to enforce compliance, it could have imposed at least $62 billion in fines for missing trial results.

Postmarket Surveillance and Regulation

Postmarket oversight and surveillance should be extended to protect patients, especially young patients, from being targeted by misleading direct-to-consumer (DTC) advertisements on social media. Recently, Senators Durbin (D-IL) and Braun (R-IN) sent a letter to Commissioner Califf raising the alarm over the troubling rise in misleading and dangerous social media content promoting prescription drugs. Since the last update to the agency’s guidance on prescription drug promotion for social media in 2014, the digital landscape has dramatically changed. Our regulating authority must keep pace. Social media influencers and telehealth companies are promoting prescription drugs without disclosing their side effects, risks or financial relationship with the messenger–flouting the traditional requirements. It is troubling that our patients of all ages are receiving medical advice from influencers and advertisements instead of discussing treatment options with their physicians. The FDA needs to be funded to capacity to ensure that it can exercise its authority to regulate fair and truthful information that is shared in DTC advertisements regardless of the platform.

In addition, we are aware that the FDA has been unable to allocate user fees for enhanced postmarket surveillance activities, including more active surveillance. As the agency increasingly approves new drugs and devices more quickly with continued questions around efficacy and safety, including across diverse populations, there is further reliance on producing evidence during the postmarket period. However, as companies may not be incentivized to do so, it is imperative for the FDA and other federal agencies to conduct such studies towards mitigating the impacts on patients and clinicians of continued uncertainty around the safety and efficacy of new products after approval. One opportunity may be through FDA’s recently announced Center for Clinical Trial innovation which, if adequately resourced, could play an instrumental role in enabling continued evidence generation.

Drug Shortages

As you are aware, prescription medicine shortages have been a chronic, ongoing problem noted by Congress and well-documented and researched. Commonly used medications are in shortage, such as some concentrations of saline, pediatric albuterol, children’s Tylenol, Adderall, and some forms of penicillin. Additionally, the current shortage of some generic cancer chemotherapies, which are first-line treatments for lung, breast, bladder, and ovarian cancers, is devastating. Thousands of patients across the country are facing delays in getting these and other treatments for cancer and other life-threatening diseases, with drug shortages in the United States approaching record levels.

Unfortunately, the FDA’s capacity to comprehensively assess the U.S. pharmaceutical supply chain and remediate known causes of shortages for critical drugs is limited by policy and budget. The FDA is currently unable to assess the percentage of life-supporting and life-sustaining medications with fewer than three manufacturers or rely on only one API supplier because it does not have a list of such drugs.

The FDA has said it needs more legislative authority and a bigger budget from Congress to obtain the information needed about drug manufacturing and supply chains. DFA strongly supports this regulatory initiative and augmented authorities, which must be accompanied by substantial budgetary expansion.

Health Equity

As you are aware, the FDA is dedicated to advancing the health of our nation’s most vulnerable and underrepresented populations. While the agency has increased efforts to advance clinical trial diversity, more needs to be done to ensure drugs and medical devices are safe and effective for racial and ethnic minority groups. For example, in 2022, a study found that pulse oximeters were far less accurate at detecting low oxygen levels for Black patients.

Medical devices have fewer pre- and post-market regulations; however, Congress could and should utilize the appropriations process to mandate that the FDA implement additional reporting mechanisms for these devices. FDA should be required to report the devices the agency is performing post-market surveillance on to ensure that the appropriate studies on race and ethnicity are being completed.

The FDA Task Force has been a vocal advocate for strengthening the FDA’s ability to enforce the highest standard and ensure that patients are prescribed therapies that are truly safe and effective across all patient populations. Clinical trial diversity is imperative for patient safety and improving public trust in our agencies. The Task Force recently submitted a public comment with recommendations related to the FDA’s Draft Guidance for Industry on the “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for Food and Drug Administration-Regulated Medical Product,” where we asked the agency to implement standard practices for capturing and reporting the collection of race and ethnicity data in clinical trials. Bolstering FDA resources will allow the agency to fulfill its commitment to addressing gaps in health equity for underserved communities and diverse populations.

By investing in the FDA’s work, Congress can demonstrate its commitment to public health, innovation, and patient safety. We urge you to provide the agency with increased funding for FY25 so it can fulfill its regulatory mission and maintain its ‘gold standard’ status. The FDA Task Force is happy to serve as a resource for the Committee during your FY25 appropriations process regarding FDA funding and authority. We will be contacting your staff shortly to request a meeting. In the meantime, should you have any questions, please contact Reshma Ramachandran, Chair of the FDA Task Force ([email protected]).

Thank you,

Doctors for America, FDA Task Force

Health Justice and Equity, FDA