Medical Dynamics

“FDA’s DTC Review Problems Highlight Industry’s Growing Legal Squeeze”

July 27, 2009

The Government Accountability Office’s report on FDA’s staffing and budgeting problems highlights the agency’s funding challenge: it’s so strapped that it often can’t even effectively assess how it’s using its resources.

The drug industry understands this issue all too well, as anyone who has waited for a meeting with a review division, hoped for a guidance document to consult, or wondered when an application might get approved, can attest.

But the 1 GAO report, released July 20, highlights another challenge for industry: while many of the agency’s review and oversight functions will probably get attention from a safety-minded Congress and administration, one area that might not – resources for advertising pre-review – is becoming increasingly important to firms.

A number of recent legal settlements between firms and state attorneys general have resulted in requirements that companies receive pre-clearance of their direct-to-consumer advertising (”2 The ‘Super FDA’: State Attorneys General Flex Their Muscle in Pharma Enforcement,” The RPM Report, January 2009).

Indeed, Merck and Schering’s recent settlement with several states related to a failed study of Vytorin did not establish any new compliance terms, but it should drive home to industry that the existing terms which the firms affirmed – from prohibiting ghost writing to reducing conflicts of interest for data safety monitoring boards – should be seen as standard operating procedure if companies want to avoid legal trouble (3 ‘The Pink Sheet’ DAILY, July 15, 2009).

Among the terms is the requirement that the soon-to-merge companies obtain pre-approval from FDA for all DTC television advertisements and comply with agency suggestions to modify the ads. So FDA’s ability to quickly review DTC ads is paramount to anyone wanting to run a consumer campaign and stay on the right side of the law.

Industry had agreed to a user fee program for DTC ad review as part of the FDA Amendments Act of 2007, only to see the House Appropriations Committee block implementation (4 ‘The Pink Sheet,’ Jan. 21, 2008).

Even so, agency support for the examination of drug-related promotional materials has grown in recent years. Staff resources increased 26 percent from fiscal 2004 to 2008, going from 35 to 44 full-time equivalents, while funding jumped 167 percent, going from about $4 million to about $10 million, according to the GAO report.

FDA is still hiring advertising reviewers (5 ‘The Pink Sheet,’ July 6, 2009) but the staffing increase over those five years was outstripped by the growth in submissions of final materials, which increased 55 percent, and draft materials, which jumped 47 percent.

The number of draft submissions is tiny compared to the final submissions (2,709 versus nearly 300,000 between fiscal 2004 and 2008) but from a compliance perspective, these are ones that industry cares most about FDA reviewing, and that appears to be going down.

During the five-year period, FDA sent a total of 2,262 letters in response to its examination of draft promotional materials, down 44 percent.

“Although FDA officials noted that the agency did not have sufficient resources to examine all drug-related promotional materials submitted for review, FDA also could not provide information on the number of such materials staff reviewed,” GAO noted.

GAO has criticized FDA’s advertising reviews before, and in response to a report issued last year, the agency said that creating a tracking mechanism would take critical resources away from the reviews themselves (6 ‘The Pink Sheet,’ Dec. 18, 2008).

One bright spot for big pharma is that as it focuses more on specialty products, it may have better luck with advertising reviews. GAO found that the agency “did examine nearly all such materials for biologics.”

Overall, while GAO noted profound shortcomings in FDA’s ability to plan for its resource needs, it was generally satisfied with the approach the agency is taking to address the problems.

The agency pledged to “complete an inventory of all regulatory work products,” catalogued by center, and is also planning a broad staffing assessment – including most notably for its contractor workforce (7 ‘The Pink Sheet’ DAILY, July 21, 2009).