Lawmakers Question FDA’s Promotion of Affordable Care Act

Republican members of the Senate Health Committee, led by ranking Republican Senator Lamar Alexander (R. Tenn.), have written to the FDA Commissioner, Margaret Hamburg, asking why and how the agency is promoting the Patient Protection and Affordable Care Act (PPACA) (P.L. 111-148), specifically the health insurance exchanges. The senators objected to emails sent via the FDA’s public email distribution system that promoted open enrollment in health insurance exchanges, offered links to webinars and described benefits of the law to families, individuals, small businesses and clinicians.

The letter, characterized by some as “blasting” the FDA, asks in part:

  1. Under what legal authority is your agency promoting implementation of the new health care law and/or insurance coverage?
  2. How do your activities further the mission of the Food and Drug Administration?
  3. In addition to the attached email, what additional activities is FDA undertaking to support implementation of the new healthcare law?
  4. What appropriations account is FDA charging for its costs in supporting implementation of the new healthcare law?
  5. What are the total costs to date and what is the amount allocated for the fiscal year for these activities?

In addition to Senator Alexander, the letter was signed by Senators Mike Enzi (R-Wyo.), Richard Burr (R-N.C.), Johnny Isakson (R-Ga.), Rand Paul (R-Ky.), Orrin Hatch (R-Utah), Pat Roberts (R-Kan.), Lisa Murkowski (R-Alaska), Mark Kirk (R-Ill.), and Tim Scott (R-S.C.). The letter pointedly remarked that the agency should focus on its mission, which includes numerous drug shortages and patients waiting for drug and medical device approvals. Whether the agency will respond to the letter remains to be seen.