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OPDP's Gray reflects on 2020's challenges, successes

Posted 25 January 2021 | By Kari Oakes 

OPDP's Gray reflects on 2020's challenges, successes

Katy Gray, PharmD

Looking back to 2020, the acting director of the US Food and Drug Administration’s Office of Prescription Drug Promotion (FDA’s OPDP) highlighted the office’s major initiatives and successes.
Speaking in a “Conversations” interview hosted by FDA’s Center for Drug Evaluation and Research, Katie Gray, PharmD, spoke of inter-agency initiatives to encourage biosimilar competitiveness, how the pandemic changed the year’s course for OPDP, and future directions.
In the pre-pandemic times of early 2020, OPDP kicked off an initiative to support competitive markets for biological products. In these efforts, the agency focused on stamping out anti-competitive statements comparing biological reference products and biosimilars. In a joint statement made with the Federal Trade Commission (FTC) in February 2020, the two agencies said, “The FDA and the FTC have serious concerns about such statements and their negative impact on public health, including their potential to create negative misperceptions about the safety or effectiveness of approved biosimilars.”
The two agencies hosted a joint public workshop in March 2020, and FDA also issued a draft guidance outlining how biosimilars and their reference products can be portrayed truthfully in promotional labeling and advertising. (RELATED: Biologic and biosimilar misinformation: FDA drafts guidance, Regulatory Focus 03 February 2020)
In the leadup to these initiatives, Pfizer and Novartis had raised concerns with FDA about advertising and promotional language that left unclear impressions about biosimilars’ quality, effectiveness and purity in comparison to their reference products. In 2018, Pfizer formally raised concerns in the form of a citizen petition.  
Gray said that OPDP focused on how biosimilars are portrayed in comparison to reference products because “misleading information could discourage people from using biosimilars, which is a big problem because the therapies can potentially increase patient access to important treatments and may lower health care costs.”
In 2020, OPDP released a total of 6 warning letters. None of them were issued to biologics manufacturers. OPDP’s Gray said that the agency will continue its information-sharing with FTC, with the common goal of supporting “the crucial adoption of biosimilars and interchangeable products.”
The “Bad Ad” program reached its 10th anniversary in 2020, noted Gray, adding that health care provides had submitted almost 2,000 reported of potentially false or misleading information related to prescription drugs by mid-2020.
The Core Launch process was updated and streamlined in 2020, with OPDP giving a refresh to the process for sponsors to submit promotional materials for drugs about to enter the market. New for 2020 is a 5-day screening period, during which OPDP staff review submissions to ensure they are complete and review-ready. “This window gives firms much faster feedback about the completeness of their submissions,” said Gray.
As COVID-19 became the world’s paramount priority, OPDP shifted its focus as well. “We went into high alert, focusing on enforcement regarding prescription drug promotional materials making false or misleading claims about COVID-19 prevention or treatment,” said Gray. Her staff have also been busy reviewing fact sheets related to emergency use authorizations for COVID-19 therapies. Other high-priority work focuses on drugs that carry elevated risk of harm with misuse, such as opioids, as well as continued follow-up of drugs that have previously been cited in compliance letters or complaints.
Some streamlining, such as electronic submissions, will outlast the pandemic, added Gray.
Social media “has not been much of a game changer for us,” said Gray. The basic set of regulatory criteria apply no matter the format, she added.
In 2020, as the pandemic continues, so will OPDP’s efforts in this area. However, said Gray, “One of our biggest priorities in 2021 is to put more of a human face on our work.” To that end, OPDP staff will participate in conferences, and generally be more visible so that industry, health care professionals and patients can learn more about the work the office conducts.  “FDA needs to stay engaged with this post-approval phase of a drug's lifecycle to support public health with truthful and non-misleading promotional communications,” she said.



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