The United States Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) had a busy 2020, like many other branches of the FDA and health-related government agencies.
Biosimilars
In February 2020, OPDP and the Federal Trade Commission (FTC) issued a joint statement outlining the shared efforts by the agencies to support competitive markets for biological products, including biosimilars. Both agencies committed to taking action on false and misleading communications about biosimilars – including false or misleading comparisons between a biosimilar and its reference product. They also committed to work together on public outreach, hosting a joint public workshop in March 2020.
OPDP also issued draft guidance on presenting data about biosimilars and their reference products in promotional labeling and advertising in 2020. The guidance includes answers to questions that manufacturers and others may have when developing their marketing materials, including specific examples.
Bad Ad Program
2020 was also the 10th anniversary of the Bad Ad Program. Under the Bad Ad Program, health care providers can report instances of potentially false or misleading prescription drug promotion. As of July 2020, almost 2,000 reports had been submitted to the Bad Ad Program by health care providers.
Warning Letters
For the entire 2020 year, OPDP issued four warning letters and two untitled letters, to companies who the agency believes were engaging in false or misleading advertising for select drugs.
The enforcement letters sent by OPDP in 2020 provide a peek into the agency’s current focus, which appears to be shifting toward promotion in online media. It will be interesting to see if the change in Administration will lead to a change in OPDP enforcement trends.
Streamlining
OPDP also used 2020 to work on streamlining some processes, including the Core Launch process. The updated process improves the initial discussion between OPDP and firms about “launch materials”, such as patient brochures and advertisements in professional journals.
Another update to the Core Launch process is the addition of a five-day screening period to the launch review process for OPDP 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.
The streamlining of electronic submissions is also expected to continue past the COVID-19 pandemic.
Looking Forward
OPDP also gave an inclination of what to expect from the agency going forward in 2021, saying it hopes to “put more of a human face on our work.” Going forward, the agency plans to make itself more visible “to make sure patients and prescribers receive accurate information about the therapies they use and prescribe,” and plans to have more OPDP staff participate in the DIA Advertising and Promotion Regulatory Affairs Conference.
As is expected, the COVID-19 pandemic will also continue to be a major focus of the agency and OPDP will continue to ensure that promotional materials intended to treat or prevent COVID-19 are accurate. Promotional materials that falsely suggest that a drug has been approved for COVID-19 will be one main target of OPDP.