Health Care

There are several specific actions the Department of Health and Human Services can take to achieve its goal of “better promot[ing] the health and well-being of the American people” via agency-wide efforts to modernize regulations, the NAM told HHS Secretary Robert F. Kennedy Jr. this week in response to a request for information.

What’s going on: “The previous administration … imposed regulatory costs of more than $350 billion per year on the manufacturing industry,” NAM Managing Vice President of Policy Charles Crain said Monday. “All sectors of manufacturing have been affected by these unbalanced regulations, including biopharmaceutical manufacturers that are impacted by regulations from HHS.”

• “Rescinding or revising unworkable regulations would unlock biopharmaceutical innovation and further cement the United States as the leader in this field.”

Price controls pushback: The NAM has long opposed the drug price controls program created by the Inflation Reduction Act. The letter notes that the program threatens U.S. “leadership in biopharmaceutical innovation” and “patient access to innovative medications.” To mitigate the program’s risks, manufacturers are encouraging HHS to:

• Resolve the so-called “pill penalty,” which subjects small molecule drugs (commonly administered as pills) to price controls earlier than other types of treatments and thus disincentivizes the development of small molecule drugs; and
• Unwind the agency’s interpretations of the terms “qualifying single source drugs” and “marketed,” which have caused drugs to be subject to price controls that otherwise would not have been.

Regulatory rebalancing: Beyond the price controls program, the NAM has identified several other problematic rules that impact manufacturers.

• Most notably, a rule proposed by the Biden Food and Drug Administration would have widespread impacts on the industry’s ability to use talc—a common manufacturing input—in both products and manufacturing processes.
• The NAM is calling on the Trump FDA to rescind the rule, which is not based on the best available science and testing standards.

The final say: “The United States can, and must, remain the leader” in biopharmaceutical innovation, Crain concluded, and rebalancing or rescinding unworkable regulations “is an important step towards that goal.”