WASHINGTON _ Stealing thunder from would-be FDA reformersin Congress and elsewhere, President Clinton unveiled a few of hisown plans on Thursday to streamline and "reinvent" drug andmedical device regulation in the U.S.
In a broader regulatory reform speech delivered at a small print shopin Arlington, Va., Clinton offered highlights of a comprehensive planfor FDA reform to be released in a few weeks. He listed five reformsthat address issues raised by drug and device manufacturers in a rashof private meetings held at the White House and the FDA in recentmonths and that grew out of Vice President Albert Gore's"Reinventing Government" initiative.
"These FDA reforms and others we will announce in the next fewweeks will keep quality at world class levels and save industry _ andconsumers _ nearly half a billion dollars a year," claimed Clinton.Three of the new reforms that relate directly to regulation of newtherapeutic drugs and biologics were outlined in an FDA briefingpaper. They include:
* Issuance of new guidelines to allow some manufacturing changeswithout prior FDA approval. The FDA will allow manufacturers tomake certain changes, such as adding an ingredient or using adifferent manufacturing facility or process, without FDA review andapproval of the proposed change. "FDA will stop doing a full-blownreview every time a biotech drug company makes a minor, risk-freemanufacturing change in an established drug," promised Clinton.
* Elimination of special statutory requirements for the regulation ofinsulin and antibiotic drug products, including a requirement that theFDA certify whether individual batches of insulin meet regulatorystandards and that it issue its own specifications for antibiotic drugs.Clinton said the change would eliminate more than 700 pages in theCode of Federal Regulations and would make products available toconsumers more quickly.
* Exemption for virtually all human drugs and biologics from thecurrent requirement for environmental impact analyses, reducing theburden on industry of submitting the assessments and on the FDA ofreviewing them.
Clinton said that the FDA also plans to exempt 140 new categories ofsimple, low-risk devices from premarket review requirements and toabolish the so-called "reference list" of device companies that haveserious manufacturing problems. In the past, firms on the list werepunished by having review of pending applications of unrelatedproducts deferred until manufacturing violations were corrected.
Industry Reps Praise Proposal
Drug industry representatives praised the President's ideas, but saidthe preliminary proposals represent only the first step towardfundamental FDA reform. They called for enforceable regulationsand legislation to be implemented as soon as possible.
"We're pleased that the President and the White House haveacknowledged that there is a problem," Biotechnology IndustryOrganization (BIO) President Carl Feldbaum told BioWorld. "Butmake no mistake, we're in this for the long haul and we're lookingforward to reviewing the more detailed, comprehensive proposals."
According to Greg Simon, Gore's chief domestic policy advisor,additional reforms could include important changes to the regulationsgoverning export of non-FDA-approved drugs and biologics.Industry has complained that rules restricting the export of suchproducts have forced companies to locate manufacturing plantsoverseas, thereby losing U.S. jobs.
Prediction: Biotech's Priorities Will Make Final Cut
Simon declined to offer additional clues on what further reforms theadministration's final FDA report will contain, saying only that it willprovide "a lot more detail about when and how we're going to makethe changes the President talked about." But Chris Jennings, a specialassistant to the President on health policy who worked closely withSimon on the White House's FDA reform project, said that "almostall of the biotechnology industry's highest priorities will be integratedinto the final report that gets released.
"Our bottom line has always been that we're interested instreamlining regulations and being responsive to the needs of industryas long as it does not undermine in any way the basic safety andefficacy charge of the FDA," Jennings told BioWorld.
Indeed, Clinton emphasized on Thursday that the FDA has madeAmerican drugs and medical devices "the envy of all the world.""And we are going to stick with the standards we have," he added.Recent public opinion polls would seem to validate theadministration's assertion that current U.S. safety and efficacyrequirements enjoy broad support.
But Republicans and conservative think tanks have argued that thegeneral public does not understand the price being paid for slow drugapprovals and burdensome regulatory hurdles. They maintain that apotentially radical restructuring of the FDA is needed.
Some Want More Dramatic
Some industry trade associations have also pressed for deeperchanges. "We applaud the Clinton administration for taking theseinitial steps but we still seek fundamental reform," Steve Berchem,spokesman for the Pharmaceutical Research and Manufacturers ofAmerica, told BioWorld.
Simon insisted that the handful of reforms outlined on Thursday wentfar beyond "tinkering" with the system and would produce significantchange. "The new manufacturing rules alone relieve thebiotechnology industry of about 50 percent of the requirements thatthey now have in terms of getting approval for manufacturingchanges," Simon told BioWorld.
According to Jennings, FDA Commissioner David Kessler has beendeeply involved in crafting the reforms and personally presented thefinal package to Gore in a private meeting. "We're not doing this tothe FDA, we're doing it with the FDA," Jennings said. "The agencyis in lockstep with us in selling this proposal." n
-- Lisa Piercey Washington Editor
(c) 1997 American Health Consultants. All rights reserved.