Biden’s competition order directs FDA on biosimilars, importation and OTC hearing aids

Regulatory NewsRegulatory News | 12 July 2021 |  By 

Prescription drug pricing, generic and biosimilar competition, and access to over-the-counter (OTC) hearing aids are among the targets of a sweeping executive order signed by President Joe Biden on Friday.
The order, aimed at promoting competition in the US marketplace across several sectors, calls on the Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) to advance several policies that are already planned or underway, including some policies pursued by the previous administration.
“Just a handful of companies control the market for many vital medicines, giving them leverage over everyone else to charge whatever they want. As a result, Americans pay two and a half times more for prescription drugs than in any other leading country. And nearly one in four Americans struggles to afford their medication,” Biden said.
One such policy includes revisiting prescription drug importation from Canada, where prices are cheaper than in the US, by instructing the FDA Commissioner to work with states and tribes that propose to develop section 804 importation programs. (RELATED: HHS opens pathway to importing Canadian drugs, Regulatory Focus 25 September 2020)
Another example is the order’s callout for FDA to publish proposed rules for OTC hearing aids within 120 days, which the agency was required to do in August 2020 under the FDA Reauthorization Act of 2017. FDA had also included rulemaking related to OTC hearing aids in its recent Spring Unified Agenda, though the deadline set for the proposed rule has also slipped by. (RELATED: Statutory deadline for OTC hearing aid rule missed by FDA, Regulatory Focus 17 November 2020; Unified Agenda: A look at FDA’s upcoming rulemaking, Regulatory Focus 17 June 2021)
“Right now, if you need a hearing aid, you can’t just walk into a pharmacy and pick one up over-the-counter. You have to get it from a doctor or a specialist. Not only does that make getting hearing aids inconvenient, it makes them considerably more expensive, and it makes it harder for new companies to compete, innovate, and sell hearing aids at lower prices,” Biden said.
The order calls on the Secretary of HHS to submit a report to the White House with a plan “to continue the effort to combat excessive pricing of prescription drugs and enhance domestic pharmaceutical supply chains.”
HHS and FDA are also instructed to “continue to promote generic drug and biosimilar competition,” as laid out in FDA’s 2017 and 2018 competition plans for pharmaceuticals and biologics. (RELATED: Gottlieb looks to boost generic drug competition, Regulatory Focus 21 June 2017; FDA to speed reviews of more generic drugs, offers lists of those with no competition, Regulatory Focus 27 June 2017; Gottlieb assesses slow biosimilar uptake in US, offers a plan to instigate competition, Regulatory Focus 18 July 2018)
Other provisions of the order directed at FDA include continuing to clarify and improve the approval framework for generics and biosimilars; clarifying standards for the approval of interchangeable biologics; supporting education and communication initiatives for biosimilars; and to continue clarifying requirements and procedures related to the review and submission of biologics license applications (BLAs).
The latter point includes a call for FDA to advance proposed rulemaking on modernizing its biologics regulations. Additionally, the Federal Trade Commission (FTC) is instructed to work with HHS to identify and address “any efforts to impede generic drug and biosimilar competition.”
Remarks, Executive Order, Fact Sheet


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you