News & Insights

Increased FDA Scrutiny Of Pre-Approval Communications Continued in 2012

Global Life Sciences: US-FDA Update

Warning and untitled letters issued to prescription drug manufacturers in 2012 reflect continued FDA focus on pre-approval communications. FDA’s Office of Prescription Drug Promotion (OPDP) last year issued two untitled letters to manufacturers alleging that pre-approval communications about investigational new drugs exceeded the scope of permissible “scientific exchange” under 21 C.F.R. § 312.7(a).1 This follows a seven-year period in which OPDP (and its predecessor, the Division of Drug Marketing, Advertising, and Communications (DDMAC)) issued no such letters, prior to which the number of letters had attained a fifteen-year high. The 2012 letters point up the importance of continued manufacturer attention to FDA’s interpretation of the pre-approval promotion rules, even as OPDP has been considering changes to § 312.7(a) since soliciting public comment on the issue in December 2011.

The two untitled letters involved conclusory statements of safety and effectiveness of the type that have drawn regulatory scrutiny in the past.

  • The October 18 untitled letter objected to statements on a website and YouTube channel regarding two investigational new drugs. The websites contained press releases, videos, and other presentations characterizing the drugs as “well tolerated,” and explaining that they “work without causing side effects” and have demonstrated “remarkable” results.2
  • The November 27 untitled letter objected to statements, on a website and in a podcast, that the drug’s “normalizing” mechanism of action allows for chronic treatment in both adults and children of different types of diarrhea, including: AIDS diarrhea; traveler’s diarrhea; diarrhea due to cholera infection; severe acute, infectious, watery diarrhea; and mild diarrhea.3

In both cases, OPDP alleged that the statements “suggested” that the unapproved drugs were safe and effective for the purposes for which they were being investigated, in violation of 21 C.F.R. § 312.7(a).

Coincidentally, both letters objected to statements appearing not in conventional print and broadcast communications but rather in digital media. In both cases, the drugs at issue were under clinical investigation pursuant to Investigational New Drug exemptions (INDs).

The regulatory prohibition on promotion of investigational new drugs at § 312.7(a) is currently under review by FDA. In response to a citizen petition filed on behalf of a group of prescription drug manufacturers in July 2011, FDA published a notice in the Federal Register soliciting comment on the scientific exchange rule.4 The petitioning manufacturers, joined by non-petitioning manufacturers under the auspices of the Medical Information Working Group (MIWG), filed comments with FDA in response to the notice. The MIWG comments point up the statutory and constitutional limitations on the scope of FDA’s authority to regulate the content of manufacturer speech that is truthful and non-misleading but concerns a use that has not been approved by FDA. The constitutional dimension of FDA’s existing approach to speech regulation has been emphasized once again in the December 3 decision by the United States Court of Appeals for the Second Circuit in United States v. Caronia.5 Sidley filed the citizen petition and the comments, and a Sidley amicus brief and law review article were cited in the Court of Appeals decision in Caronia.6

The 2012 untitled letters reflect FDA’s commitment to continued enforcement of the prohibition on pre-approval promotion by manufacturers across a range of media, even as the agency continues to review comments and considers the issues identified in the notice against a backdrop of judicial decisions acknowledging important constitutional limitations on the regulatory scheme.


[1] The relevant text of the regulation provides: “A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.”

[2] OPDP, Untitled Letter to Burzynski Research Institute, Inc. re Antineoplastons A20 and AS2-1 (Oct. 18, 2012), available here.

[3] OPDP, Untitled Letter to Salix Pharmaceuticals and Napo Pharmaceuticals, Inc. re Crofelemer (Nov. 27, 2012), available here.

[4] Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed; Request for Information and Comments, 76 Fed. Reg. 81,508 (Dec. 28, 2011).

[5] United States v. Caronia, No. 09-5006-cr (2nd Cir. Dec. 3, 2012), available here.

[6] Coleen Klasmeier & Martin H. Redish, Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection, 37 Am. J.L. & Med. 315 (2011).

February 5, 2013

FDA Practice

For further information on the FDA Practice, please contact:

Raymond A. Bonner

Coleen Klasmeier

Global Life Sciences Practice

For further information on the Global Life Sciences Practice, please contact:

Scott Bass

To receive Sidley updates via email, please click here.

Sidley Austin provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship.

Attorney Advertising - For purposes of compliance with New York State Bar rules, our headquarters are Sidley Austin LLP, 787 Seventh Avenue, New York, NY 10019, 212.839.5300; One South Dearborn, Chicago, IL 60603, 312.853.7000; and 1501 K Street, N.W., Washington, D.C. 20005, 202.736.8000.