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No Guidance, But the FDA is Studying Social Media Impact

By Mari Serebrov

Washington Editor

WASHINGTON – In yet another signal that it's seriously considering drugmakers' use of social media, the FDA plans to survey health care professionals on the impact direct-to-consumer (DTC) drug promotion, whether online or in traditional media, has on their practice.

"With the proliferation of social media platforms, the emergence of online pharmaceutical marketing and evolution of office detailing practices . . . FDA will benefit by knowing more about health care professionals' awareness of new and emerging drug promotion sites and practices," the agency said.

The survey comes 10 years after a similar one in which general practitioners and specialists were asked about the influence DTC promotion had on their practice. In the 2002 survey, which focused on traditional DTC advertising, about a third of the respondents said such promotion had no influence. The rest were about equally divided on whether drug promotion had positive or negative influence, according to an FDA notice being published in the Federal Register Tuesday.

"Over the past decade, researchers have been able to better assess how DTC advertising has unfolded in the United States and determine the questions that warrant further survey work," the agency said, adding that questions about influence "have grown more urgent with the growth of DTC advertising."

The new survey also will reflect other health care trends, notably the increased role of nurse practitioners and physician assistants. The FDA hopes to get 2,000 respondents – 500 each from general practitioners, specialists, nurse practitioners and physician assistants. It plans to recruit respondents from a national Internet health care professional panel and various professional organizations.

The survey is just one effort the FDA is taking to assess drug promotion and social media. The agency's Office of Prescription Drug Promotion (OPDP) is planning a study, expected to be completed in 2014, to test various ways of presenting prescription drug risk and benefit information on branded drug websites. (See BioWorld Today, Jan. 11, 2012.)

That study is intended to complement qualitative research OPDP plans to conduct on various social media issues.

While most of the FDA's social media efforts seem to be geared at studying the issues, the agency did provide some direction on social media in a recent guidance on how to respond to requests for off-label information.

Comments on the FDA's proposed survey must be submitted by March 17.

MedPAC Proposes Restructuring Co-pay

To rein in Medicare Part D costs, the Medicare Payment Advisory Committee (MedPAC) wants to do more to encourage use of generics, especially among low-income subsidy (LIS) beneficiaries.

Noting that LIS beneficiaries tend to fill more prescriptions, spend more per prescription and use more brand drugs than other Medicare beneficiaries, the committee approved a recommendation to restructure LIS co-pays to encourage generic or therapeutic substitutions.

(A therapeutic substitution involves a switch from a nonpreferred brand drug to a preferred brand drug or from a brand drug to the generic form of a different drug in the same therapeutic class.)

Under the recommendation, which will be included in MedPAC's March report to Congress, there would be no LIS co-pay for a generic drug and the co-pay for brand drugs would be increased significantly. In an example presented at MedPAC's meeting last week, the $3.30 co-pay for a brand drug would be increased to $6.

The proposed policy calls for broad authority and flexibility in determining appropriate therapeutic classifications, with some drug classes possibly being excluded.

In addition to reducing Part D spending, MedPAC recognized that the policy could increase beneficiaries' adherence to their medications.

Watchdog Calls for Yaz Advisory Committee

Citing past conflicts of interest for some members of a joint advisory committee that considered the risks of Bayer HealthCare Pharmaceuticals Inc.'s Yaz and Yasmin last month, the Project on Government Oversight (POGO) is asking FDA Commissioner Margaret Hamburg to convene a new advisory committee – free of ties to Bayer – to re-evaluate the safety of the birth control pills.

In response to rising concerns about the risk of venous thromboembolism with drospirenone-containing oral contraceptives, the FDA convened the joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in December. The panel voted 15-11 that the benefits of the drugs outweighed the risks.

The POGO noted that four members, including the acting chairwoman, had past ties to Bayer that were not disclosed. All four voted for the drugs.

"In the future, if a reasonable person would have questions about the impartiality of any member of an advisory committee regarding a matter before the committee, the FDA should not allow that member to participate in the matter and should make public the relevant information about that committee member," POGO said in a letter to Hamburg last week.

The government watchdog also asked the agency to draft new guidelines requiring fuller public disclosure of potential conflicts of interest, including the online posting of each member's FDA 3410 form.

The agency is finalizing draft guidelines to deter conflicts of interest, but the episode shows those guidelines are too weak, according to the letter. New guidelines "should address the matter of impartiality beyond a direct conflict of interest," POGO said. (See BioWorld Today, March 26, 2007.)

The group acknowledged that dealing with an advisory committee member with a conflict of interest can be a difficult judgment call, but the "call should not be made by FDA officials behind permanently closed doors."

First Hearings Set for PDUFA, Biosimilar Fees

A House subcommittee will start the congressional ball rolling on the fifth reauthorization of PDUFA and the inauguration of biosimilar and generic user fees.

The Energy & Commerce Committee's Health Subcommittee will hold a hearing on PDUFA Feb. 1 . FDA Commissioner Margaret Hamburg is scheduled to testify about the user fee agreement, which is set to expire Sept. 30 if it's not reauthorized. (See BioWorld Today, July 11, 2011, and Oct. 26, 2011.)

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, is slated to testify Feb. 7 during the subcommittee's hearing on the new generic drug and biosimilar user fees. (See BioWorld Today, May 10, 2011, June 10, 2011, Dec. 7, 2011, and Dec. 19, 2011.)

The FDA submitted the user fee/performance goal agreements, negotiated with industry, to Congress Friday.