Former FDA Official Questions Agency Role in Drug Pricing
Former FDA regulatory counsel and now-partner at Spencer Fane Brian Malkin is questioning whether the agency should become more directly involved in the Trump administration's drug-pricing initiatives, raising concerns about the potential direction of FDA policy under commissioner nominee Heidi Overton, whose nomination remains pending in the Senate.
Malkin, who previously served in FDA's Office of the Commissioner and CDER for nine years, said Overton's involvement in White House drug-pricing policies could make reducing pharmaceutical costs an early priority if she is confirmed. Speaking on a 10/12 FDA Watch podcast, Malkin noted he would not be surprised if Overton pursued initiatives related to the administration’s most-favored-nation pricing policies, which seek to bring U.S. drug prices closer to those paid in other countries.
However, he questioned whether direct involvement in pricing decisions would be appropriate for FDA. “That's not really FDA's business because FDA is looking for safety and efficacy and evaluating the products from those criteria,” he said.
Malkin distinguished FDA’s regulatory responsibilities from those of the Centers for Medicare & Medicaid Services (CMS), which administers federal health insurance programs and has a more direct role in drug payment and reimbursement policies. He acknowledged that FDA’s generic-drug and biosimilar programs can influence pharmaceutical prices by encouraging competition, but questioned whether the agency should take on a broader role in pricing policy.
His comments come amid a broader discussion about whether FDA should incorporate drug affordability more systematically into its regulatory policies.
In a recent article in the Journal of Health Politics, Policy and Law, former FDA Principal Deputy Commissioner Joshua Sharfstein and Johns Hopkins researcher Caleigh Propes proposed expanding the agency's role in addressing drug costs through stronger generic competition, changes to accelerated approval oversight, increased transparency and selective use of enforcement discretion (FDA Webview, October 5).
Sharfstein and Propes recommended that Congress authorize FDA to work with CMS to limit Medicare Part B and Medicaid payment rates for drugs granted accelerated approval until their clinical benefits have been confirmed. Their proposal would leave payment decisions with CMS while using FDA's regulatory oversight of confirmatory trials to help determine when payment restrictions should end.
The authors also urged prioritizing generic applications in markets characterized by high prices and limited competition, expanding access to FDA clinical data for independent assessments of therapeutic value, and potentially exercising enforcement discretion when extraordinarily high drug prices effectively prevent patients from obtaining needed medicines.
While Malkin emphasized the limits of FDA's pricing responsibilities, Sharfstein and Propes argued that drug affordability can be a legitimate public-health consideration in certain agency policies.
The positions nevertheless share an important principle: Sharfstein and Propes also oppose allowing drug prices to influence FDA’s scientific safety and effectiveness determinations.
Malkin expressed uncertainty about how Overton would approach these boundaries, given her work on administration drug-pricing initiatives. He suggested that she might seek to collaborate with other federal agencies on reimbursement and drug-selection issues, potentially bringing FDA into policy discussions traditionally handled elsewhere within HHS.
At her September Senate confirmation hearing (see earlier story), Overton identified increasing access to affordable treatments among her priorities and defended the administration's efforts to reduce prescription drug prices. She also told lawmakers that individual FDA product reviews and approval determinations should remain within the agency and follow statutory requirements.
Malkin said it remains difficult to predict Overton's management approach or the regulatory changes she might pursue if confirmed. He suggested that her decisions involving senior agency officials and organizational priorities during her first 100 days would provide an early indication of her direction.