The Complete Pharm Exec Guide to PDUFA - Pharmaceutical Executive

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The Complete Pharm Exec Guide to PDUFA
What Congress's grand plans for the "revitalization' of FDA really mean...besides more red tape


Pharmaceutical Executive


The history of prescription drug laws is a complex mix of evolution and politics—in particular, the politics following real or perceived public health crises. The bipartisan PDUFA IV legislation currently pending in Congress is no exception: The bills—the Senate FDA Revitalization Act (S. 1082) and the House FDA Amendments Act (H.R. 2900)—would both continue existing programs and create new regulatory burdens.

In essence, the user-fee framework and pediatric-research laws will likely remain in place, while FDA will have new powers to increase postmarket safety monitoring, impose civil penalties, and require drug manufacturers to register post–Phase I clinical trials and results in a national database. A "placeholder" is also included in the Senate bill for approval of follow-on biologics, but the details of such a contentious issue are unlikely to be hammered out before October 1, when PDUFA III sunsets.

Many drug companies have no doubt followed the congressional path of PDUFA IV—not to mention the near-constant media debates about drug safety, FDA accountability, and industry transparency in whose shadow the bills were drafted. But most firms are only beginning to consider the upcoming legislation's practical impact on their operations and products. To get you moving, Pharm Exec offers this guide to PDUFA IV—detailing the many provisions the two bills have in common as well as their few, but telling, differences. But reader, beware: At press time, the two versions of the legislation had not yet moved to conference, so what follows is a best guess about what PDUFA IV will look like.

The Safety Issue

PDUFA I was originally enacted in 1992, in the midst of a very different type of controversy: a widespread concern—driven by AIDS activism and industry lobbying—that FDA had inadequate resources to approve drugs fast enough and was lagging behind other nations in permitting lifesaving therapies to come to market. Although some continued to question the propriety of a bargain between industry funding and agency regulatory activities, the user-fee framework was showing promise, and PDUFA II in 1997 further developed the user-fee model as part of broader FDA-modernization legislation, providing additional resources for critical FDA drug-review.

The 2002 version of PDUFA, passed as part of bioterrorism legislation, sought to enhance the stability of FDA drug-review funding and to introduce a new element: limited use of user-fee funding to address growing concerns about postmarket drug-risk management.

Despite these efforts, a series of drug safety concerns—whipped into a "crisis" by congressional investigations, FDA "whistle-blowers," and product-liability litigation—made many in industry fear that PDUFA IV would become a vehicle for onerous new regulatory requirements. In particular, some predicted wholesale structural FDA reform that would ensure a disproportionate focus on postmarket safety relative to the benefits of drugs for patients.

In fact, PDUFA IV is heavily focused on drug safety—and that means more regulation. Yet, despite the rhetoric, longtime congressional leaders on FDA issues have sought to channel the frenzy over drug safety into "FDA revitalization" rather than unproductive reform. These legislators have focused on enhancing postmarket drug safety monitoring, while making FDA's activities more transparent and independent. Although most in industry hope to see changes to troubling provisions in the pending bills, the general consensus is: "It could have been worse." If the bills are properly modified and implemented reasonably, the result could be a stronger FDA that engenders greater public respect for difficult drug safety decisions.

1 User Fees

Certain members of Congress once again advocated killing the Prescription Drug User Fee Act outright this time, claiming that user-fee funding of the drug-review process has created an inappropriate industry–agency interdependence. But in the end, budget realities left those arguments with little traction. In fact, both pending bills will not only reauthorize the user-fee program but extend it into areas far beyond the legislation's original mandate of drug review. And, not surprisingly, total annual user fees will increase to $393 million a year—about one-quarter of the agency's $1.6 billion yearly budget.


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