WASHINGTON _ The White House on Thursdayreleased what Vice President Al Gore called the most"comprehensive overhaul of regulations affectingbiotechnology drugs in the history of the FDA.
"The regulatory reforms will save millions of dollars,thousands of pages without sacrificing the safety of theprocess or the product," he told a gathering of reporters,industry leaders and administration officials at the OldExecutive Office Building.
"However, these reforms prove that we do not have tocompromise one iota of America's health or safety inorder to benefit America's economy."
Gore described the package of reforms, which werestruck by leaders of the biotechnology industry and FDACommissioner David Kessler late last month, (seeBioWorld Today, Oct. 31, 1995, p. 1) as "common senseregulatory reforms that will stimulate continued growth inthe biotech industry and additional jobs that will permitthe FDA to focus its resources on real safety issues."
The improvements standardize the regulation of biotechand synthetic drugs by eliminating many regulatoryrequirements that were an artifact of traditional biologicsregulations.
"The reforms announced today are the result of hard workand close collaboration between biotech industry officialsand the FDA," Gore said.
Gore and other senior Clinton administration healthofficials made a point of highlighting the collaborationbetween the industry and the FDA that had produced theadministrative reforms. They also made a point ofdistancing themselves from conservative congressionalRepublicans who have proposed much more fundamentalchange in FDA's role as a public health agency.
"The U.S. is the leader in biotechnology, the leader inbiotech drugs and the leader in biotech drug safety andwe intend to keep it that way," Gore said.
"As President Clinton said earlier this year when heannounced FDA reforms, we can and will do more tokeep America's biotech industry number one in theworld."
Sen. Edward Kennedy (D-Mass.), who was instrumentalin bringing Massachusetts biotech firms to meet withFDA officials to discuss what reforms the agency couldmake internally, extolled the government-industrycollaboration as a "partnership at its best."
A `New State Of Mind'
Sen. Barbara Mikulski (D-Md.), who last April upbraidedKessler at a Senate hearing for not being responsive to thebiotech drug industry (see BioWorld Today, April 19,1995, p. 1) reflected that in the past the "FDA wassometimes slow and was obsessed with safety andefficacy.
"But that day is over," she said. "This new regulatoryframework reflects a new state of mind between the FDAand the biotech industry."
Mikulski agreed with biotech industry leaders that there isstill a need for FDA reform legislation. "We need to lookat how we can streamline the entire process whilemaintaining safety and efficacy," she told BioWorldToday. Mikulski said she is looking forward to workingwith Senate Labor and Human Resources CommitteeChairwoman Nancy Kassebaum (R-Kan.) on her FDAreform plan.
Industry leaders dismissed notions that the FDA hasmoved far enough to take the pressure off Congress toenact FDA reform legislation. "What they have donetoday should be codified into legislation," saidBiotechnology Industry Organization president CarlFeldbaum. "The industry needs that reliability so that itisn't subject to another administration, another FDA justundoing what was done today. And there are other issuesthat were not addressed today that we need to deal withadministratively."
Some of the reforms announced are effectiveimmediately. Mary Pendergast, senior advisor to Kessler,said that letters were sent to biotech manufacturers onThursday informing them that that lot releaserequirements were not longer applicable. A formal noticewill be published later in the Federal Register.
In early December the FDA will hold a public hearing todiscuss a better way to define well-characterized biotechproducts. Kathryn Zoon, director of the FDA's Center forBiologics Evaluation & Research, said the meeting willexamine whether the definition of well-characterized canapply to more complex formulations.
Within 45 days the FDA will publish a notice in theFederal Register which will eliminate the establishmentlicense application (ELA) for most biotech drugs. Therule is expected to become final in mid-April, saidPendergast.
Promo Materials For Biotech Same As Synthetic
Several new policy initiatives not discussed earlier thismonth also were announced. Deputy FDA commissionerfor policy Bill Schultz told reporters that the regulation ofearly promotion materials released for biotech drugs willbe put on the same footing as synthetic drugs. Now bothwill not be required to submit promotional materials tothe FDA for approval when the materials aredisseminated. Previously, biotech firms had to submit thematerials prior to product launch.
Schultz also pledged the agency's intention of reviewingand responding to clinical holds placed on investigationswithin 30 days.
Requiring a more complicated bureaucratic clearancewith the administration is FDA's proposal to replace withone form the 21 different approval applications forms forbiotech drugs, blood, vaccines and other drugs.
In addition, the FDA will no longer require that eachbiotech company designate only one person to deal withthe agency, giving companies flexibility to staff theirregulatory affairs divisions. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.