WASHINGTON – If a mention in two guidances is enough to establish a trend, social media is definitely trending at the FDA.

The agency released a final guidance Tuesday on the juxtaposition of proprietary and established names in drug advertising and promotion. One of the things that set the new guidance apart from the draft published 13 years ago, the FDA said, is that this one includes a section on "electronic and computer-based promotional labeling and advertisements, such as Internet promotion, social media, emails, CD-ROMS and DVDs."

Basically, the guidance clarifies when and how to use the established name of a drug (the active pharmaceutical ingredient) along with the brand name in advertising and promotional materials. But the recommendations for computer-based promotion are more applicable for static promotional websites than they are for social media channels such as Facebook or Twitter.

In the guidance, the FDA recognizes the difference between computer-based media and traditional media. "However, promotional labeling and advertising in such media often contain running text equivalent to many pages of traditional printed text," the agency said.

When the brand name is part of the running text in computer-based promotions, the established name must accompany the brand at least once. If the running text spans more than one screen, the FDA recommends that the established name accompany the brand name at least once per screen.

When the brand is used in headlines, taglines, logos, footnotes, graphs or pictures rather than in the running text, the established name is required to accompany the brand name each time it appears.

Late last month, the FDA incorporated social media in a draft guidance on responding to unsolicited requests for off-label information. Although the agency is starting to advise on social media-related concerns in guidance where appropriate, it has not said whether it is still working on a long-promised guidance devoted to social media issues. (See BioWorld Today, April 7, 2011, Aug. 19, 2011, Nov. 14, 2011, and Jan. 11, 2012.)

PCORI Drafts Research Agenda

The Patient-Centered Outcomes Research Institute (PCORI) is inching toward starting the job it was created to do two years ago, with hopes of awarding its first research grants in May.

But first, the institute has to set its research agenda. PCORI is seeking comments, through March 15, on the first draft of its national research priorities and agenda, based on five areas where comparative-effectiveness research is needed to support health care decision-making.

The priorities focus on assessing options for prevention, diagnosis and treatment; improving health care systems; communicating and disseminating research; addressing disparities in health outcomes; and accelerating patient-centered outcomes research and methodological research.

Calling the agenda a starting point, PCORI Executive Director Joe Selby said it will provide a framework and "identify the broad questions that must be addressed so that patients can make better and more personalized decisions in partnership with their clinicians."

After reviewing submitted comments and feedback from a public forum next month and focus groups, PCORI will adopt its final priorities and agenda before issuing awards.

Established by the 2010 Affordable Care Act as a nonprofit corporation tasked with identifying priorities for comparative-effectiveness research, PCORI received 856 applications last year for $26 million in grants to fund projects supporting the development of research methods, patient-oriented outcomes instruments, patient-provider communication and other decision-making strategies. It expects to fund about 40 projects. (See BioWorld Today, Sept. 27, 2010, and Sept. 29, 2011.)

PTO to Study Genetic Diagnostic Patent Issues

As part of its charge under the America Invents Act (AIA), the Patent and Trademark Office (PTO) will hold two public meetings in the next two months to gather comments on genetic diagnostics, which are at the heart of personalized medicine.

The first meeting is scheduled for Feb. 16 in Alexandria, Va., with the second meeting to be held March 9 in San Diego. Both meetings will be webcast, according to a notice to be published in the Federal Register Wednesday.

The PTO will use comments from the meetings for a study it is required to conduct under the AIA. The study must address the following:

• the impact that the lack of independent, second-opinion testing has on the ability to provide the highest level of medical care and innovate on existing tests;

• the effect that providing independent, second-opinion genetic diagnostic testing would have on existing patent and license holders of an exclusive test;

• the impact that exclusive licensing and patents on genetic testing has on the practice of medicine, including the interpretation of results and performance of testing procedures;

• the role that cost and insurance coverage has on access to genetic diagnostic tests.

Patents on genetic diagnostics have come under fire in a number of court challenges, including The Association for Molecular Pathology v. Myriad Genetics Inc., which has been appealed to the Supreme Court, and Mayo Collaborative Services v. Prometheus Laboratories Inc., which is awaiting a Supreme Court decision. (See BioWorld Today, Aug. 2, 2011, Dec. 8, 2011, and Dec. 9, 2011.)

Concerted Effort Needed to Combat Abuse

To treat the growing epidemic of prescription pain reliever abuse, federal agencies should do a better job of coordinating their educational efforts and evaluating the outcomes of those efforts, the Government Accountability Office (GAO) said in a new report.

The GAO noted that several government agencies, including the FDA and National Institutes of Health, use a variety of strategies to educate prescribers about the dangers of painkiller abuse. The FDA's efforts are often included in risk evaluation and mitigation strategies required for drugs with high potential for abuse. (See BioWorld Today, Nov. 30, 2011, and Dec. 2, 2011.)

"But only two agencies have established or are planning to establish metrics to assess the impact of their efforts on audiences' knowledge, attitudes and behavior," the GAO said. "Without outcome evaluations, federal agencies have limited knowledge of how effective their efforts are."

The GAO recommended that the Office of National Drug Control Policy establish outcome metrics for all the agencies, implement a plan to evaluate proposed educational efforts and ensure agencies share lessons learned.