If you've been paying close attention to the US Food and Drug Administration's (FDA) emails over the last several weeks, you've likely caught onto something unusual: the agency's promotion of something that has almost nothing to do with food, drug, medical devices or other regulated products.
That thing, as it turns out, is the Patient Protection and Affordable Care Act (PPACA) - "Obamacare," if you like - President Barack Obama's signature health care overhaul reform measure that is set to provide healthcare to tens of millions of currently uninsured US citizens.
A 31 May 2013 email received by Focus under the heading, "Open enrollment in the Health Insurance Marketplace begins on October 1, 2013 and coverage takes effect in January 2014," caught our attention as being the first instance of FDA ever mentioning the PPACA's insurance provisions.
What made it particularly unusual, however, was that it was submitted via FDA's "Drug Information Update" distribution list, ordinarily reserved for sending out information pertinent to the pharmaceutical industry.
The email itself explains the benefits of the PPACA's provisions to individuals, families and other consumers, closely mirroring points made by the US Department of Health and Human Services (DHHS), the agency's parent organization.
But the email also raised some questions among partisans in Congress, and in particular Republican members of the Senate's Health, Education, Labor and Pensions (HELP) Committee who are now publicly wondering whether the agency should be promoting the law at all.
In a letter posted to the HELP Committee's website on 19 June 2013, Sens. Lamar Alexander (R-Tenn.), 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.) all said they believed that FDA's emails "appear to be outside of your agency's mission to approve and regulate lifesaving medical products in a timely manner and keeping our food supply safe."
The emails apparently extended to more entities than just the pharmaceutical industry, the senators said.
"We are writing to ask why and under what authority the Food and Drug Administration (FDA) is using its time and resources to enroll Americans in health insurance marketplaces created by the new health care law," they wrote. On June 3, 2013, the FDA sent a notice to families, individuals, small businesses and clinicians promoting insurance market changes in the new health care law.
The problem, they continued, is that FDA's communications "should reflect your agency's actual statutory mission to assure the safety of food, drugs, and medical devices." Enrollment in insurance - something being coordinated by DHHS' Centers for Medicare and Medicaid Services (CMS) - would "appear to be outside of your agency's mission," they said.
Threat to Funding?
The letter, personally addressed to FDA Commissioner Margaret Hamburg, reminds her in not-so-subtle terms of the challenges FDA is now facing, including drug shortages and a general scarcity of resources. Both houses of Congress are currently assessing FDA's budget request, and the mention of both could be an implicit threat to make the appropriations process more difficult for FDA.
"While our nation suffers from numerous drug shortages and patients are waiting for drugs and medical device approvals, the FDA should not be using resources designated for these purposes to fund an effort unrelated to your agency's mission of 'assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation,'" they said.
The letter concludes by requesting that, by 26 June 2013, Hamburg respond to the following five questions:
- Under what legal authority is your agency promoting implementation of the new health care law and/or insurance coverage?
- How do your activities further the mission of the Food and Drug Administration?
- In addition to the attached email, what additional activities is FDA undertaking to support implementation of the new healthcare law?
- What appropriations account is FDA charging for its costs in supporting implementation of the new healthcare law?
- What are the total costs to date and what is the amount allocated for the fiscal year for these activities?
HELP Committee Letter