OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part VI)
In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years. Parts I, II, III, IV and V focus on Hatch-Waxman, medical privacy laws, FDA’s user fees, prescription drug traceability and GMPs. Today’s blog looks back at changes in the regulation of drug promotion.
As we celebrate anniversaries at OFW Law this month (the firm’s 35th and my 21st), any retrospective on the drug practice would be incomplete without recognizing our work on, and the changes to, how entities communicate with patients and consumers about prescription drugs.
We could go back to Lydia E. Pinkham’s Pills Vegetable Compound and earlier for evidence of “patent” drug promotion directly to consumers. However, this retrospective begins in 1962, when Congress enacted the Kefauver-Harris Amendments to the FDC Act. In addition to expanding FDA’s authority over prescription drugs, and requiring proof of safety and efficacy prior to approval and marketing, Congress also transferred from the FTC to FDA the authority over the advertising of prescription drugs.
Pursuant to that authority, in 1963, FDA initiated and finalized the rulemaking that would eventually become the familiar § 202.1 – Prescription-drug Advertisements (28 Fed. Reg. 1448 (Feb. 14, 1963); 28 Fed. Reg. 6375 (June 20, 1963). The requirements that a prescription drug promotion be fairly balanced and accompanied by appropriate information (the full prescribing information (“PI”) for promotional labeling and a brief summary of that PI for advertising) have been with us – seemingly forever – and without substantial change. If it seems that existing regulations don’t fit modern healthcare communications very well, look no farther than the fact that the regulations are older than both today’s popular technologies and most of the people who use them for prescription drug information.
FDA cites the early 1980’s as the point when prescription drug sponsors first began targeting patients and consumers directly – what became known as “direct-to-consumer” or “DTC” promotion. FDA requested a voluntary moratorium on DTC prescription drug promotion on September 2, 1983 and, thereafter, undertook a series of public meetings and research. The agency lifted the moratorium two years later (56 Fed. Reg. 36,677 (Sept. 9, 1985)), stating that it believed current regulations provided “sufficient safeguards” for consumers.
(Keep in mind, just getting copies of regulatory documents was an adventure in those days. Paralegals with rolls of nickels and good contacts would traverse from the downtown Federal Register office to Fishers Lane and back, scrounging for documents put on public display.)
In August 1995, FDA announced the first of several public hearings on DTC-related issues (60 Fed. Reg. 42,581 (Aug. 16, 1995)). Two questions FDA posed were of special interest: what information should accompany print promotion; and how to satisfy the disclosure requirements for broadcast advertisements. Nearly 20 years later, these issues continue to vex prescription drug communications.
Accompanying Information in DTC Print Communications
Under 21 U.S.C. § 352(n), any print advertisement must be accompanied by “information in brief summary relating to side effect, contraindications, and effectiveness,” which FDA had interpreted in 21 C.F.R. § 202.1(e)(3)(iii) to mean “each specific side effect and contraindication” in the drug’s PI.
This meant that magazine and newspaper ads would include a page or more of solid text that reprinted most or all of the PI in a tiny font. At the 1995 public hearing, then-FDA Associate Director for Medical Policy, Dr. Robert Temple, bluntly acknowledged that this approach for consumer-directed communications was an oxymoron:
Let’s say we all agree for the sake of argument that the current brief summary, which is neither brief nor a summary – like the Holy Roman Empire was neither holy nor an empire – isn’t very helpful. I think you won’t find a great deal of disagreement about that among FDA staff either.
Unanimous condemnation of the PI-based brief summary in DTC promotion would continue through several more rounds of comments and FDA research that showed, unsurprisingly, that consumers found it no more useful than FDA staff did.
In 2004, FDA released the Brief Summary Draft Guidance which expressed the agency’s decision to exercise enforcement discretion and, the requirements of 21 C.F.R. § 202.1(e)(3)(iii) notwithstanding, permit and encourage abbreviated, consumer-friendly brief summaries with DTC print advertising. Marketers implemented the draft guidance, hugely improving DTC print promotions.
Unfortunately, the agency never addressed what has, in the last 10 years, become an enormous problem in other patient-directed communications. The Brief Summary Draft Guidance only helps DTC print advertising (e.g., magazines and newspapers) – media that are in significant decline. The Draft Guidance does not apply to patient-directed labeling, like refill reminders and compliance and adherence communications given to patients to support their prescribed and dispensed therapy. FDA still interprets its requirements as mandating patient-directed labeling to be accompanied by the full PI, even though the agency has long acknowledged (and has the data to prove) that the PI isn’t helpful to patients.
Keeping patients compliant is an enormous, costly, and deadly public health problem and everything that can be done should be done to make these communications easier, better, and more accessible. Since the release of the Brief Summary Draft Guidance in 2004, the agency has been urged, repeatedly, to do for patient-directed labeling what it did for DTC print advertising. It never has.
In February, there was cause for hope when FDA’s Center for Drug Evaluation and Research (CDER) published its proposed Guidance Agenda and announced it would finalize the 2004 Brief Summary Draft Guidance. This was good news, even if it would have little impact as so little DTC advertising remains in traditional print media and anyone still in that space adopted the consumer-friendly brief summaries years ago. More exciting was the new title of the Guidance:
Brief Summary and Adequate Information for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs.
(Emphasis added.) It appears that FDA may take the opportunity the guidance provides to address the heavy disclosure burden placed upon patient-directed promotional labeling that the DTC advertising does not have to meet. Maybe, hopefully, compliance and adherence communications patients need for the safe and effective use of their prescribed and dispensed drugs can finally be accompanied by a useful, brief summary of the PI rather than the full PI.
“Adequate Provision” for DTC Broadcast Advertisements
That seminal 1995 DTC hearing also addressed the dilemma § 202.1 posed for prescription-drug broadcast advertising. Under 21 C.F.R. § 202.1(e)(1), sponsors of broadcast advertisements are, among other things, required to present a brief summary in the advertisement or, alternatively, must make “adequate provision … for dissemination of the approved or permitted package labeling in connection with the broadcast presentation.”
This requirement made it impossible for manufacturers to promote DTC prescription drugs in regular broadcasts. No one knew what “adequate provision” of the PI meant. The brief summary was too long for the typical broadcast commercial, though advertisers would scroll through a drug’s brief summary or PI at the end of video presentations made at medical conferences – a measure that was as technically compliant as it was utterly useless.
In 1997, FDA issued a Draft Guidance on Consumer-Directed Broadcast Advertisements that explained how manufacturers could make “adequate provision” for the PI in a broadcast ad. 62 Fed. Reg. 43,171 (Aug. 12, 1997). To satisfy adequate provision requirements, a prescription drug advertisement needed to identify several mechanisms describing where a consumer could obtain the product’s PI. These included a toll-free number, a concurrent advertisement in a print publication, and an Internet URL. The agency finalized the Guidance in 1999.
With this new clarity, TV prescription drug ads blossomed and have been highly controversial ever since. FDA’s Office of Prescription Drug Promotion now has an extensive procedure for voluntary, pre-dissemination advisory review of both DTC TV ads and other materials. In March 2012, FDA issued a draft guidance addressing when and how it would use its statutory authority under the FDA Amendments Act of 2007 to review prescription drug television advertisements prior to dissemination. The guidance was highly controversial and FDA stated it would not begin pre-dissemination review until the guidance was final. According to CDER’s agenda discussed above, this guidance is also slated to be released in final in 2014.
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As we draw to the end of the year and continue celebrating OFW Law’s anniversary, we’re still waiting on the Brief Summary Guidance that will – we hope – resolve a problem that has vexed patient-directed compliance communications for decades. If we do see the final guidance on pre-dissemination review of DTC TV ads in 2014, it should make for interesting reading given the vociferous objections to the draft guidance. With so many marketers turning away from traditional media, we do wonder how much it will matter. We’ll look at that next generation – prescription drug promotion in social media – in another retrospective coming soon.