The political tensions wrought by last November's mid-term elections will affect pharmaceutical manufacturers in many ways
in the coming year. Congressional Republicans will seek to cut the federal deficit by squeezing resources to government agencies,
including the US Food and Drug Administration. New House leaders may also seek opportunities to criticize lax regulatory oversight
and drug quality failures that compromise product safety. Pressure on federal agencies to appear as tough regulators and to
obtain additional revenues will intensify government efforts to fine violative companies and to ratchet up industry user fees.
Challenges to the Obama administration's healthcare reform program are likely to create uncertainties about whether new fees
and policies will be implemented as planned. The alternative is that manufacturers may have to pay stiffer rebates and taxes
without the benefit of gaining millions of additional customers as part of a reformed affordable-access health-insurance system.
The conventional wisdom is that President Obama has one year to enact any new legislation or establish new programs before
the political infighting becomes even more intense leading up to the 2012 Presidential elections.
The Prescription Drug User Fee Act (PDUFA) has to be reauthorized by Oct. 1, 2012, in order for FDA to continue collecting
nearly $700 million in fees to support the review process for drugs and biologics. Although that legislative deadline may
seem far away, FDA wants to have a PDUFA V plan ready for public review by fall in order to transmit it to Congress early
2012. Failure to reauthorize user fees by next summer theoretically would force FDA to lay off hundreds of staffers and shut
down its drug review process.
In April 2010, FDA's Center for Drug Evaluation and Research (CDER) launched a two-year process for revising PDUFA. CDER Director
Janet Woodcock noted that 65% of human drug review funding comes from user fees, a situation that some critics claim makes
the agency overly dependent on industry. Yet, despite some qualms about the current program, no one suggests that FDA curtail
any activities or cancel the fees.
Bio/pharmaceutical companies offered general support for user fees, while pointing out that multiple postmarketing requirements
are slowing down the drug-review process and undermining approval timeframes. Patient advocates, pharmacists, and doctors
agreed that the proliferation of risk evaluation and mitigation strategies (REMS) made drug development more costly and complicated
prescribing and dispensing. Consumer groups focused more on direct-to-consumer (DTC) drug advertising, seeking user-fee support
for mandatory pre-review of DTC advertisements, clearer prescribing information, better protection of patients in clinical
trials, and more comparative studies to ensure that new drugs are superior to those already on the market.
FDA has been discussing these and other issues at meetings with manufacturers, patient and consumer groups, healthcare professionals
and academic experts, as part of a broad, transparent consultative process required by the FDA Amendments Act (FDAAA) of 2007.
A key FDA goal for PDUFA V is to gain more flexibility in meeting review timeframes and responding to sponsor meeting requests.
The agency has proposed extending the review clock for more complex applications such as those with REMS, those that require
advisory committee meetings, or those that involve inspections of foreign manufacturing facilities. But manufacturers fear
that most new drug application (NDAs) would qualify for extensions under these criteria.
The overarching issue is to what extent industry fees should fund FDA initiatives to improve drug development and regulatory
science. FDA proposes to tap fees to increase staff consultations on quality-by-design and other complex manufacturing issues,
on innovative clinical trial designs, on using biomarkers in drug development and for standardizing electronic submissions.
Additional resources also could support the Sentinel active surveillance system, standards for meta-analysis, biomarker qualification,
development of treatments for rare diseases, and improved dose selection and drug-safety assessments. But this year's fee
to process an NDA with clinical data already exceeds $1.5 million, up from $1.17 million in 2008, and manufacturers are wary
that expanding the pool of activities supported by PDUFA would boost industry outlays disproportionately.
Many of these issues will be addressed by Congress as it crafts a broader FDA reform bill that includes PDUFA reauthorization.
As with FDAAA, this "must-pass" legislation will be a prime candidate to carry measures establishing a host of new FDA policies
and programs: curbs on drug advertising, expanded drug reimportation, ban on pay-for-delay deals between innovator and generic-drug
makers, refinements to the REMS program, new requirements that drugs demonstrate comparative superiority, and enhanced FDA
authority to pull drugs off the market and to issue subpoenas are some of the possibilities.