Unlocking the Truth: Addressing Drug Pricing and Healthcare Fraud Challenges – Insights from JD Supra

Key Takeaways

• Robert F. Kennedy Jr. and Marty Makary’s strategies as HHS Secretary and FDA Commissioner are yet to be defined.
• The Trump administration may concentrate on lowering drug prices and healthcare expenses. Current subsidies for Affordable Care Act plans will likely end soon.
• Health care fraud, digital health, and data privacy will likely see increased regulatory attention.
• The FDA aims to improve cybersecurity for medical devices and develop guidance for AI-based software.
• Reauthorization of the over-the-counter monograph drug user fee program can address medical issues like drug shortages.

Drug prices and healthcare costs are big topics for the new administration, as ongoing legal battles around drug price negotiations are expected. Despite some wins in court for the pharmaceutical industry, the Centers for Medicare and Medicaid Services plan to keep implementing the Inflation Reduction Act (IRA). The public and lawmakers are focused on making healthcare more affordable, which is likely to keep the push for drug price negotiations strong, regardless of the litigation outcome.

However, the discussion about lowering healthcare costs may clash with the upcoming expiration of subsidies for those using Affordable Care Act plans. This could lead to higher costs for many Americans.

Health care fraud is another area of focus. The FDA and the Department of Justice are working to prevent:

• Fraud in clinical trials.
• Cybersecurity risks to health information.
• Mishandling of product support.
• Complex arrangements for product referrals.

Digital health and data privacy will also remain under scrutiny. The FDA plans to tackle guidance around medical device cybersecurity and AI software in the coming fiscal year.

HHS Secretary Insights

If Robert F. Kennedy Jr. becomes Secretary of the Department of Health and Human Services, we can expect him to get more involved with FDA matters. He has already shared his views on various topics such as:

• Revising vaccine policies.
• Looking at how drugs are advertised to consumers.
• Relaxing some rules for alternative therapies.

The actual impact of his views remains uncertain. Meanwhile, if Marty Makary is appointed as FDA Commissioner, he’s known for valuing scientific evidence, despite his criticisms of the medical establishment.

Over-the-Counter Drug User Fee Program

A key piece of legislation for the FDA is the reauthorization of the over-the-counter monograph drug user fee program (OMUFA), which expires this year. This program requires OTC drug manufacturers to pay fees for marketing their products.

While reauthorizing OMUFA should be straightforward, such bills often open doors for discussions on other important issues. Recent topics that may be addressed include:

• Managing drug shortages.
• Creating protections for “skinny labeling” to avoid generic patent issues.
• Ensuring biosimilars can be substituted for brand names without needing extensive studies.
• Expanding FDA inspection authority, especially after past recalls.
• Updating the Dietary Supplement Health and Education Act for better oversight.

We also expect the FDA to continue its efforts to tackle the opioid crisis and to explore using real-world evidence for drug approvals, especially for rare diseases.

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