Pharma’s Headache Becomes Writer’s Meal Ticket

Is REMS on your radar? If not, it should be. This growing federal program presents a potential new source of income for both freelance and staff medical writers.

REMS stands for risk evaluation and mitigation strategy. (Technically the acronym is singular, but it sounds plural, so many writers use it that way.) The REMS program was created by the Food and Drug Administration Amendments Act of 2007 as a way to make sure the benefits of new drugs outweigh the risks.

More than 180 risk mitigation strategies have been approved by FDA so far. More are being created every month: 42 were created or updated during the first quarter of 2011. Some are short and simple, others are long and complex.

Approved strategies come in 3 main types. The simplest type requires a medication guide that is distributed inside the drug package (or single dispensing unit, as a pharmacist might say). The medium complex type is called a communication plan, and it adds a “Dear Healthcare Provider” letter explaining the particular risks and benefits of the medication. The communication plan may also involve a small amount of education. The highest level of complexity is called Elements to Assure Safe Use (ETASU). This level is rare; only 21 had been approved by 2011. FDA reserves this step for drugs that are easily misused or abused, such as painkillers. The ETASU for Abstral (fentanyl) sublingual tablets, for example, is 123 pages long, and that just describes the program, it does not include the copy required for the special Web site, the letters to healthcare providers, the certification program for pharmacists, the pharmacy knowledge assessment, and the letters to distributors. As you can see, the REMS program represents a headache for pharma because the money to produce all of these materials comes out of the manufacturer’s pocket. This is why industry spoke out so strongly at an FDA advisory hearing last summer on the future of REMS.

MEAL TICKET

Marilyn Whiteley, PharmD, senior director for global medical writing at PPD Inc. in Morrisville, North Carolina, gave a presentation on REMS at the AMWA national conference in Milwaukee. According to Whiteley, the REMS program presents a valuable work opportunity for medical writers because of the diversity of materials required, the sheer size of some of the programs, the need for consistency and clarity, and the fact that many strategies, once approved, must be updated or renewed on a periodic basis. The best way to position yourself for success in this new market, Whiteley says, is to educate yourself, look for transferable skills, get trained in the areas where you are weak, then market yourself.

In the next year or 2, we can expect to read and hear more about REMS for a class of painkillers called opioid analgesics. Federal public health officials are very concerned by recent statistics showing increased misuse, abuse, and diversion of the extended release and long-lasting forms of these painkillers. These are the types of REMS that often are the most extensive, and therefore offer the greatest employment opportunities. The FDA will determine what must be included, and it will be up to the pharmaceutical companies to decide whether to do the work in-house or outsource to contractors. Pharma won’t just be hiring medical writers: these programs also involve Web design, graphic design, marketing, and continuing education expertise including needs assessment and instructional design.

CME POTENTIAL

The continuing education angle was seized upon by Murray Kopelow, MD, executive director of the Accreditation Council for Continuing Medical Education in Chicago. Dr Kopelow traveled to Washington DC last summer to testify at an FDA advisory hearing, reminding the FDA that accredited CME providers would be delighted to help physicians and pharmacists earn continuing education credit while attending training programs required under future REMS.

A similar approach is being taken by George Mejicano, MD, MS, FACME, president of the Alliance for Continuing Medical Education. This summer, the Alliance issued a joint press release with 5 other organizations expressing strong support of certified CME within the FDA’s REMS program for opioids. Exactly how to fund these activities without violating the ACCME standards for commercial support has not yet been worked out, so stay tuned.