WASHINGTON _ The FDA is considering a number ofadministrative reforms that would in effect put theregulation of biotechnology drugs on a more equalfooting with synthetic therapeutics. The changes also aresimilar to provisions in at least one FDA reform billpending in Congress.

The FDA's planned regulatory changes would define awell-characterized biotechnology drug and stipulate whena manufacturer would be exempt from lot releaseinspections and establishment license applications(ELAs).

The Clinton administration promised last April when itunveiled its "Reinventing Drug & Medical DeviceRegulations" initiative that additional proposals to reformthe regulation of drugs and medical devices were underdevelopment and would be announced later (SeeBioWorld Today, April 18, 1995, p. 1).

The planned reforms, which still have not been approvedby FDA Commissioner David Kessler, would standardizethe manufacture of biotech drugs with synthetic drugs.Bruce Mackler, a partner with the Palo Alto, Calif.-basedFenwick & West law firm and founder of the Associationof Biotechnology Companies, the predecessor to theBiotechnology Industry Organization, said the plannedrule will permit biotech companies to contract out manyof their manufacturing processes just as syntheticcompanies now do. "Biotech companies will be able tocontract out several functions and still fulfill theregulations. The old axiom, `The company that owns themanufacturing processes owns the drug,' will no longerapply," he said.

The planned regulation does away with the old notionthat "biotechnology could not be characterized," saidMackler. "That was true for vaccines that were not verypurified. But the technology to make biotech drugs hasbecome so advanced that it can stand on an equal footingwith compounders that create synthetic products," hesaid.

FDA's draft plan is expected to be well-received onCapitol Hill. "One aspect of the FDA reform debate thathas had a broad bipartisan consensus was that FDA needsto significantly redefine the way it treats biologicalproducts," said Steve Jenning, aide to Rep. Ron Wyden(D-Ore.), the author of the first reform plan introduced inCongress this year (See BioWorld Today, April 5, 1995,p. 1). "If this is the way the FDA is headed, it is headed inthe right direction," he said in an interview withBioWorld Today.

Mackler said the initiative "reflects the maturing ofscience to characterize methods (used in biotech drugmanufacturing) and the increasing sophistication of themanufacturing process which is approaching the samelevel of control and consistency as synthetic drugmanufacturers."

Enhancing FDA flexibility on manufacturingrequirements that biotech firms would have to meetwould also facilitate the "virtual" biotech corporation thatcontracts out most of its functions. The planned rulechange would enhance the "investment made by anumber of companies into contract manufacturers,"Mackler said. "These relationships will be permitted tomature. The upshot will be that the FDA will accept thesame manufacturing arrangements they have built overthe years with synthetic drug makers."

By exempting manufacturers from ELA requirements, themost important regulation that would control themanufacture of biotech products would be GoodManufacturing Practice (GMP) requirements. This shiftin effect would relocate the authority over themanufacturing process from central FDA headquarters,which controls ELA approvals, to FDA field personnelwho are responsible for GMP enforcement, said Mackler."By transferring inspection authority from the centraloffice to the field is consistent with previous FDAinternal reforms," he said.

Mackler termed the FDA and BIO as victors in the longmonths of negotiations that produced the draft regulatoryplan. "It's a big victory for BIO because they areadvancing their agenda of regulatory reform. And it's abig victory for Kathryn Zoon, director of the FDA'sCenter for Biologics Evaluation and Research (CBER),who realized that appropriate changes can be madeirrespective of the tradition ingrained in the bureaucracy,"he said.

Zoon and BIO President Carl Feldbaum negotiatedseveral months over the planned changes. They were firstput forward by BIO in the form of a "White Paper" thatwas presented to the FDA in February. Industry officialssubsequently met with Zoon and Kessler to discuss waysto reduce the inconsistencies between the Centers forDrug Evaluation and Research (CDER) and CBER.Those negotiations paid off last week when Zoonindicated the agency's intentions to go ahead with thethree planned regulatory changes, said Feldbaum.

Feldbaum cautioned that the FDA draft may be changedand that the "final details have not yet been worked out."

The issue of how to define a well-characterized biotechdrug will be explored at a planned FDA public hearing inmid-December. n

-- Michele L. Robinson Washington Editor

(c) 1997 American Health Consultants. All rights reserved.