Pharmaceutical drug pricing is back in the national debate in the wake of Mylan’s recent price increases to its EpiPen medication. This recent action has renewed the focus and attention by lawmakers and regulators alike, and once again raises the question of the role to be played by the Food and Drug Administration (FDA) in regulating drug pricing and ensuring drug competition in the wake of these recent drug price hikes.
In response to recent price hikes – including Turing’s Daraprim, Valeant’s Nitropress and Cuprimine, and Retrophin’s Thiola – Democratic presidential candidate Hillary Clinton penned an October 2015 letter to acting FDA commissioner expressing concern over the dramatic price increase in certain drugs that do not have generic competition, citing the example of Turing Pharmaceuticals. In her letter, Secretary Clinton ceded that the FDA had no legal authority to regulate drug pricing and competition, but suggested that the Agency could take a more prominent role in addressing price concerns by accelerating the generic approval process. Clinton urged the FDA to “expedite any pending reviews, and encourage applications for review, of other generic alternatives to Daraprim, and make these drugs available to U.S. patients as quickly as possible consistent with safety and efficacy.” Clinton also suggested that the FDA should consider accelerating approvals or allowing for temporary importation from other OECD countries. Clinton cited Executive Order 12588, which allows the FDA to expedite its regulatory reviews when it determines such review would help to avoid or mitigate existing or potential drug shortages. In the past, FDA has allowed for temporary importation of drugs to remedy a treatment shortage in the United States, after careful inspection of facilitates and confirmation that the imported drugs meet safety standards.
While Secretary Clinton’s letter might signal actions that may be taken by the FDA in the future to regulate or otherwise curb increasing drug prices, her letter highlights critical limitations on the FDA’s legal ability to provide oversight and regulation of drug prices. Once again, the question is posed as to which Federal agency (if any) is best poised to regulate drug pricing. In response to these mounting concerns regarding drug pricing, affordability, and access, lawmakers (both at the State and Federal levels) have launched multiple investigations and inquiries into prescription drug pricing. Thus, legislative responses are likely forthcoming, and, in some cases, have already been implemented.
With all eyes on drug companies from Congress and regulatory agencies, companies working in the life sciences should anticipate increased regulation and ensure that they are in compliance with existing applicable laws, regulations, and industry standards to avoid potential liability. Experienced counsel is critical to remaining abreast of these rapidly developing legal and regulatory changes. For assistance navigating the drug pricing regulatory landscape, drug life cycle management, and ensuring your pharmaceutical company’s compliance with State and Federal law, including antitrust laws and anti-fraud laws, contact Frier Levitt today.
