Risk and Restrictions

It's well known that many drug safety problems arise because people fail to take medicines as prescribed or pay attention to warnings. Food and Drug Administration officials seek to improve communication about the risks of medical products by the agency, industry, and interest groups through a Strategic Plan for Risk Communication unveiled September 30.

Jill Wechsler

The plan outlines ways to strengthen the science behind effective risk communication on food and medical products, explained Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), at the Food and Drug Law Institute's (FDLI) September advertising and promotion conference. It offers specific strategies for improving risk messages and for coordinating actions to better manage safety information, product recalls, and food safety alerts—without scaring consumers, Woodcock noted.

The last section of the plan proposes to "optimize" safety policies by taking a fresh look at FDA's legal framework for regulating drug advertising along with labeling and sponsor interactions with health professionals. The agency wants to reassess whether drug labeling laws designed for promotion directed at healthcare professionals fit the world of DTC advertising, or if they foster overly technical messages that block an understanding of risk issues. FDA will weigh whether recommended changes can be accomplished by revising current regulations, or if new legislation is needed.

Going "social"

If the latter, there are lots of proposals on Capitol Hill that curb drug marketing, including a ban or limit on DTC advertising for two years after product approval. An Institute of Medicine expert panel backed such a move in its 2005 report on drug safety, and the policy almost made it into the FDA Amendments Act of 2007 (FDAAA). The American College of Physicians recently backed the two-year DTC ad limit, along with another IOM proposal that all new drugs carry a special "just approved" symbol on their labels for two years to alert patients and prescribers that only limited information is available on the drug.

Other measures before Congress would require comparative effectiveness information on drug labels and ban the commercial use of prescriber data. A drug marketing "death penalty" proposal, says attorney John Kamp, would curb DTC advertising by eliminating the tax deduction allowed pharma companies for advertising expenditures. Even though such a policy supposedly would raise billions to support health reform, the proposal has not gone far because of staunch opposition from broadcasters and publishers.

One Document, Please

The Strategic Plan also proposes to streamline and improve the system for providing useful written information on drug use and side effects directly to patients. The current system is confusing and inefficient, with patient package inserts, medication guides and other communiqués. Pharmacists evidently hand out required documents to patients, but much of the information falls short of being "useful." Despite years of writing rules and guidances and holding public meetings on the subject, the surveys show that consumers don't read the information they get and don't understand what they do read.

FDA weighed new options at a two-day workshop in September on promoting patient access to timely and accurate information on drug risks. The current thinking is to replace the various hand-outs with a single standard document for communicating "essential information" about prescription drugs. That concept has considerable appeal, but still raises questions about which drugs warrant special consumer information and how to make the documents useful and readable. Manufacturers have long objected to requiring written information on all drugs, and pharmacists don't want more pieces of paper to store, track, and distribute. One solution is to provide the information electronically, but pharma companies are nervous about third parties changing content and language in the process. For now, FDA plans more studies on the format and content of written patient information, and more discussion to follow.

The value and content of written consumer information on drugs has become a hot-button issue as FDA establishes more Risk Mitigation and Evaluation Strategies (REMS) that require distribution of these documents. FDA has approved 63 new REMS in the last two years, Woodcock noted at the FDA Regulatory and Compliance Symposium in September. Of those, 47 require MedGuides, while the others involve more restrictive risk management programs. CDER now seems to require some kind of REMS for most new molecular entities, and that trend promises to greatly expand written patient information.

A one-document policy for drug handouts may inform ongoing efforts to revise the brief summary of risk information required in print drug ads. The conventional wisdom is that this document is neither "brief" nor an informative summary, and that it needs a complete makeover to be a more useful tool. CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) has been examining brief summary options for years and continues to test patient response and comprehension of different formats, reported Helen Sullivan of DDMAC's research team at the FDLI conference. Pollsters evidently are asking overweight people in shopping malls to look at different types of ads with brief summaries for a fictitious diet drug and indicate which format they like and understand the best. A design that resembles the "drug facts" label for over-the-counter drugs seems to come out on top, but the old dense format doesn't do too badly either.

More Studies and Guidance

DDMAC researchers are very busy these days. In addition to the brief summary survey, there's a study underway evaluating whether TV commercials should include a toll-free number for consumers to report adverse events to FDA. FDAAA required call-in information in print ads, but held off on broadcast to assess whether adding this message would detract from conveying risk information in commercials. FDA is revising study designs with an eye to rolling out a survey next year.

Another research project is examining how visual effects in TV commercials distract consumers and impede comprehension. The results should help FDA set standards for how marketers can best present a "major statement" on drug risks in DTC ads in a "clear, conspicuous and neutral manner," another FDAAA provision that should produce a proposed rule next year.

A related study will examine how well consumers understand clinical efficacy information in print and broadcast ads. The plan is to survey physicians and consumers to see how differently (or similarly) they perceive such information. Also on DDMAC's agenda is a plan is to assess whether adding quantitative information on risks and benefits can help consumers understand risk and efficacy claims and end point information. And another FDAAA-required report will assess how well DTC advertising communicates information to population subsets, such as the elderly, children, and ethnic minorities; DDMAC director Tom Abrams expects it to be out soon.

Meanwhile DDMAC is ramping up enforcement efforts to ensure proper disclosure of drug risks. Abrams reported at the FDLI conference that it had issued 33 regulatory letters as of September 15, 2009 (10 warning letters and 23 untitled letters). Omission and minimization of risk information is the most egregious violation, followed by promoting unapproved uses.

FDA hopes to reduce those violations by finalizing guidance on presenting risk information in drug and device promotion. FDA issued draft guidance in May 2009 that covers the risk-communication waterfront: safety disclosure in ads and labeling for both drugs and medical devices, directed to both consumers and health professionals. The guidance cites multiple examples of promotional pieces that omit or minimize risk information, even for products with boxed warnings and serious adverse events. FDA discusses in detail the content and format of promotional materials and how it will look more at the "net impression" of whether risk information is fair and balanced.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at jwechsler@advanstar.com