Regulatory Roundup

More changes at OGD

FDA’s Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER) will be headed by agency veteran Kathleen Uhl, pending a broad search for a permanent director. Uhl is stepping in to fill the void left by the surprise departure of OGD head Gary Geba in March after less than a year on the job (see “CDER Runs into Trouble with Generic Drug Reorg Plan” at blog.PharmTech.com). Uhl is not well known in the generic drug industry, but has held a range of important positions at FDA, namely head of the agency’s Office of Women’s Health and most recently deputy director of CDER’s Office of Medical Policy. She faces difficult tasks at OGD--implementing a more efficient application review process, overseeing more-timely field inspections, and establishing the new generic drug user-fee program. A key challenge is to manage a reorganization of OGD to fit plans for CDER’s new Office of Pharmaceutical Quality. Manufacturers have been dismayed by three years of management changes at OGD and hope that Uhl will bring some stability and sense of purpose to the operation. She may hold the job for a while, as it took some two years for Geba to come on board.

FDA budget crunch

Even though FDA fared comparatively well in Congressional action to fund the federal government for the rest of the current fiscal year, which ends Sept. 30, 2013, the agency still has to absorb hefty reductions required by the federal budget sequestration mandate. That mandate imposes a 5% additional cut on current funding, which will compel FDA to tighten up operations and postpone new initiatives. FDA officials have predicted a drop in field inspections and anticipate problems meeting application review time frames, scheduling meetings, developing new guidance documents, and other activities. One important positive development is that the continuing budget resolution approved by Congress just before the end of March authorizes FDA to collect all its user fees, including increases in existing fees and new levies for generic drugs and biosimilars. FDA fee revenues, however, could be subject to the 5% sequester curb; those payments are left in the federal Treasury, further intensifying the squeeze on agency resources.

Supreme Court weighs key drug issues

Two major cases slated to be decided by the high court in June promise to have a major impact on manufacturers and FDA policies, and every legal pundit in Washington is assessing the implications for food and drug law and drug development and marketing. The first case, Mutual Pharmaceutical Co. v. Bartlett (docket no. 12-142), raises questions about whether lower courts can challenge FDA regulatory decisions. A key issue is when and how generic-drug makers should revise labels to reflect important safety issues, even if the changed label differs from that of the innovator product. The case involves a patient who took Mutual’s generic drug and suffered adverse events; the patient sued and won a $21-million judgment based on the company’s failure to warn of the drug’s potential dangers. Mutual argues that the long-marketed, anti-inflammatory drug and its label were approved by FDA, and the Justice Department agrees with the manufacturer and FDA that states can’t override federal regulatory decisions. A ruling in favor of Bartlett would undermine the FDA approval process and open the door to a new wave of drug liability cases. Such a decision also might spur action to revise FDA statute so that injured consumers can sue generic makers, which would gain the right to change labels to add new warnings. This is the third case in recent years that has raised generic-drug safety labeling issues, and there’s growing pressure to clarify the rules.

The second case, FTC v. Activis (formerly Watson Pharmaceuticals) (docket no. 12-416), has received extensive media attention, as it challenges “pay-for-delay” patent settlements between brand and generics manufacturers that determine when a generic competitor comes to market. The Federal Trade Commission (FTC) has long attacked “reverse payment” deals as collusive, anti-competitive, and harmful to consumers and now wants the Court to declare them per se illegal. Brand and generics firms counter that the arrangements avoid costly litigation and actually permit generics to come to market prior to patent expiration. Congressional Democrats have proposed legislation to ban industry settlements and are watching the Court action closely.

FDA articulates benefit-risk approach

As specified by last year’s FDA Safety and Innovation Act (FDASIA), FDA is implementing a standardized approach for assessing the benefits and risks of new drugs and biologics during the application review process. A new five-year plan lays out the agency’s approach (1). Beginning in 2014, FDA reviewers will issue a benefit-risk summary stating the rationale for regulatory action. Approval decisions will consider the severity of the condition treated, available treatment options, and the toxicities of the test product. The agency also will note relevant factors that could raise uncertainties, such as toxicology data, clinical pharmacology, and chemistry, manufacturing and controls information. Although FDA has been incorporating risk-benefit analysis into agency programs and decisions for several years, the plan provides a more “consistent and systematic approach,” which is “exactly what the patient community asked for,” according to the National Health Council. FDA seeks comments on the plan and will update it as necessary.

Reference

1. FDA, “Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making,” www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm329758.pdf, accessed Apr. 9, 2013.

Jill Wechsler is Pharmaceutical Technology’s Washington editor, tel. 301.656.4634, jwechsler@advanstar.com. Read Jill’s blogs at PharmTech.com/wechsler