A requirement to determine the comparative value of new drugs is on Consumers Union's wish list for inclusion in the next round of prescription drug user fee legislation.

To gain approval for an indication, clinical trials should test new drugs against the medicine considered to be the "best practice" for treating the condition, CU health policy analyst William Vaughan explained during an interview. This would provide consumers with information that enables them "to choose the most effective product," he said.

CU is discussing its list of priorities for legislative action with other consumer and patient advocacy groups as it prepares for a larger role in user fee discussions. The FDA Amendments Act requires FDA to obtain input from the group, as well as health care professionals and scientific and academic experts, prior to negotiating with industry on the level of user fees and what they will finance; and to meet with the advocacy groups monthly as negotiations with industry progress. FDA plans to begin seeking input on March 1, 2010.

The last round of negotiations resulted in more funds for drug safety oversight and the addition of new FDA safety authorities in FDAAA ('The Pink Sheet, Oct. 1, 2007), and advocacy groups would appear to have an even better chance of affecting legislation with FDA under a Democratic administration.

But the political climate in 2012 - when PDUFA V will go before Congress, and the president, the House and one-third of the Senate are up for reelection - remains an unknown.

Building On Momentum For Comparative Effectiveness

CU's support for a comparative effectiveness standard suggests that FDA will likely find itself in the midst of debate regardless of what happens with the topic as health care reform legislation moves forward this year.

Sens. Jack Reed, D-R.I., and Barbara Mikulski, D-Md., have a bill that would encourage adding comparative data to product labeling, a version of which has made it into the Senate Heath Committee's reform bill (Also see "Opening Product Labeling To Broader CE Data Is Proposed In Senate Bill" - Pink Sheet, 25 May, 2009.). A permanent comparative effectiveness program, which is also included in reform proposals, could also dramatically change the data landscape, even if FDA had an arm's length relationship with it.

Industry would likely oppose revising FDA's approval standard to include a "best practice" comparator. AstraZeneca CEO David Brennan, for example, has noted that comparative data is a de facto requirement for bringing a product to market in many categories, but says that a new FDA requirement would not help the development process (Also see "AstraZeneca CEO Brennan Talks About Cutting Deals and Dealing With Change" - Pink Sheet, 20 April, 2009.).

User Fees, DTC, And Other Goals

One of CU's goals - user fees to fund FDA review of all direct-to-consumer advertising - may find industry backing, but that does not mean it will be adopted. An FDAAA provision supported by industry to fund FDA evaluation of TV commercials was rejected by House appropriators (Also see "DTC User Fees Rejected By House Approps Panel As FDA Safety Funds Get Boost" - Pink Sheet, 23 July, 2007.).

Many in industry would like to see DTC user fees because of the increasing number of consent decrees with prosecutors that require firms to presubmit ads for FDA clearance (Also see "FDA's DTC Review Problems Highlight Industry's Growing Legal Squeeze" - Pink Sheet, 27 July, 2009.). Without a user fee program, marketing schedules could become unpredictable as firms wait for word from FDA to avoid potential legal problems.

But Consumers Union's vision of a user fee program is far different than what industry thinks of it as - paying fees for a predictable review schedule. CU wants to disconnect user fees from approval deadlines to "help restore scientific integrity, morale and drug approval safety at the FDA," Vaughan contends.

And CU's support of FDA authority to ban advertising for three years or more for new products, a provision abandoned during the FDAAA debate (Also see "Risk Disclosure In Drug Ads Will Be FDA’s Focus After House Defeats DTC Ban" - Pink Sheet, 25 June, 2007.), is an indication that even if the advocacy group and industry both support DTC user fees, they are not exactly going to be working together on the issue.

Other items on CU's wish list are: a prohibition on importation of potentially unsafe drugs, devices and ingredients, and publication of information about Phase I trials after development of the drug ends or the drug is approved so other scientists can avoid wasting time and money repeating failed lines of research.

CU also want for congressional funding for a regular program of unannounced inspections of manufacturing facilities, at least once every two years, likely will be part of discussions when legislators consider import safety legislation (Also see "Import Safety Legislation: Generic Firms Could Accept Fees, Not Delays" - Pink Sheet, 2 March, 2009.).

-Cathy Dombrowski (c.dombrowski@elsevier.com )

PDUFA V "Wish List" From Consumers Union Includes Comparative Effectiveness Standard

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