FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) works to help ensure that prescription drug promotion is truthful and not misleading. It does so through comprehensive surveillance, compliance, policy, and education programs. The office also fosters better communication of drug labeling and promotional information to health care providers and the public.
In this CDER Conversation, Katie Gray, Pharm.D., acting OPDP director, speaks about the office’s 2020 achievements and 2021 goals, its COVID-19 response, and the ways OPDP continues to streamline operations to fulfill its public health mission.
What were some of OPDP’s accomplishments last year?
Like the rest of FDA and CDER, we had a busy 2020.
Early in the year, we were part of a multipronged initiative to help support competitive (open and fair) markets for biological products, including biosimilars. A biosimilar is a biological medication. It is highly similar to, and has no clinically meaningful difference from, a biological medication already approved by the FDA known as its reference product. This means you can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would the reference product.
To this end, we released a joint statement with the Federal Trade Commission (FTC) outlining our shared efforts on this priority. These efforts include taking action on false and misleading communications about biosimilars, such as false or misleading comparisons between a biosimilar and its reference product. We also committed to work with FTC on public outreach, and we held true to that promise when we hosted a joint public workshop with FTC in March 2020.
We also issued a draft guidance on presenting data about biosimilars and reference products included in promotional labeling and advertising in a way that is truthful and non-misleading. The guidance addresses questions firms may have when developing these kinds of materials and provides specific examples.
These activities advance our public health mission 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. We will continue to share information with FTC and work together on our mutual goals that ultimately aim to support a strong marketplace for biological products and the crucial adoption of biosimilars and interchangeable products.
We celebrated the 10-year anniversary of our Bad Ad Program in 2020 as well. This program lets health care providers report instances of potentially false or misleading prescription drug promotion. Health care providers can be our biggest advocates, and we are thrilled with their participation in this program. As of July 2020, health care providers had submitted nearly 2,000 reports to the Bad Ad Program. This From Our Perspective article about the Bad Ad Program shows the good work the program has done in this past decade.
At the end of the year, we updated and streamlined our Core Launch process. The updated process improves our initial discussion with firms about their “launch materials”— the promotional pieces for drugs just entering the market, such as patient brochures and advertisements in professional journals. Because launch materials introduce the product to a mainstream audience, these materials are a priority for OPDP to review.
As part of our 2020 update to the Core Launch process, we added a five-day screening period to the launch review process for our staff to determine whether the firm’s submission is complete and ready for review. This window gives firms much faster feedback about the completeness of their submissions. We also clarified what we consider to be core launch materials.
The COVID-19 pandemic changed the course of everything in 2020 — including some of OPDP’s work priorities. We went into high alert, focusing on enforcement regarding prescription drug promotional materials making false or misleading claims about COVID-19 prevention or treatment. In September 2020, we issued a warning letter to a firm for falsely stating its drug could treat COVID-19 symptoms. We’ve also been involved in reviewing Emergency Use Authorizations for COVID-19 therapies, reviewing written materials (e.g., fact sheets) to make sure they are accurate and not promotional in tone.
What is on tap for the year ahead?
One of our biggest priorities in 2021 is to put more of a human face on our work. We want firms, health care providers, patients, and the lay public to better understand what we do. We want to be more visible in our work with industry to make sure patients and prescribers receive accurate information about the therapies they use and prescribe. With that in mind, we plan to have more OPDP staff participate in the DIA Advertising and Promotion Regulatory Affairs Conference so that industry can put a face with the name of the person or people reviewing their materials.
The pandemic remains a major public health priority, and OPDP will continue to help make sure that promotional materials for drugs intended to prevent or treat COVID-19 are accurate. And we will continue to target promotional materials that falsely suggest that a drug has been approved for COVID-19 when it has not.
We are also working on additional policy, regulatory and social science agendas. Please stay tuned to see what we release in the year ahead.
How has COVID-19 affected your day-to-day operations?
In addition to working to fight the pandemic, OPDP has adjusted our daily operations to help keep everyone safe in this unusual time. With most OPDP staff and stakeholders working at home, we have modified how we accept materials. We have moved away from paper and are accepting electronic submissions through an additional online portal. The 6-inch paper stacks of background information are becoming a thing of the past; references, correspondence and promotional materials can now be submitted electronically.
After the pandemic, I see OPDP continuing to take advantage of technology to make things simpler and faster for our staff and the firms we work with.
How are social media and other new forms of advertising changing OPDP’s work?
Surprisingly, social media has not been much of a game changer for us. Yes, there are different types of (and more) promotional materials, but we use the same approach when we review these materials for truthful and non-misleading benefit and risk presentations. Firms still need to fulfill FDA regulatory requirements; it doesn’t matter what the platform is. Last year, we enforced these requirements in two warning letters concerning sponsored links, which are advertisements that appear on a search results webpage.
In addition, we have issued four guidances pertaining to social media. We continue to consider these and other social media topics as we work, more broadly, to develop policy about prescription drug promotion.
What promotional communications does your office prioritize?
In terms of specific prescription drug categories, we focus on promotional materials for high-risk drugs, such as opioids. We want to make sure the promotional materials accurately convey the risks associated with these drugs, convey responsible use of opioids, and do not inadvertently contribute to the opioid epidemic. We also prioritize drugs approved under a Risk Evaluation and Mitigation Strategy and other drugs with labeling that include boxed warnings regarding potentially serious side effects. And, as I said, we are focused on drugs used for COVID-19.
Other high-priority items include first impression launch materials for newly approved drugs, as I mentioned before; new uses for approved therapies; products that have been the subject of previous compliance letters; and drugs cited in complaints to the agency or promoted in far-reaching campaigns.
What is notable about your work?
The fact that the bulk of our work occurs after the drug is approved, although we do review a prescription drug’s proposed labeling before approval.
It’s important to recognize that the drug lifecycle does not end with FDA approval. Prescription drug promotional messages can have a tremendous impact on public health. These messages can affect prescribing practices as well as patient use. 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.