A new House draft of FDA reform legislation incorporates a numberof provisions from the Senate bill and suggestions frombiotechnology industry advocates. But whether there's enough timein the legislative session to get a bill passed remains to be seen.

"We're very pleased with the bill," Carl Feldbaum, president of theBiotechnology Industry Organization (BIO), said Thursday. "Itcontains accommodations we can live with. Mainly it shows acommitment to move the process forward. This bill should make iteasier for Democrats to come on board, as well as the [Clinton]administration."

The bill, called the Drugs and Biologics Reform Act of 1996 (HR3199), is expected to be marked up Wednesday. No date has been setfor a floor debate or vote. The Senate bill, however, is scheduled tobe heard on the floor on July 23 and 26, 1996.

Feldbaum said the rewrite of HR 3199 by the House CommerceCommittee makes it fairly consistent with the Senate version, "whichis a good thing because we don't have a lot of time. This is the bestchance we have for enactment this year."

Among the changes to the House bill are provisions givingcompanies more rights when trials are put on hold, easingrequirements for proving efficacy, allowing third-party accreditationof applications, and reducing manufacturing burdens. (For relatedstories see BioWorld Today, May 3 and June 19, 1996, p. 1.)

Feldbaum said in general the bill would put biologics on a level fieldwith synthetic, chemically produced drugs, instead of requiringmakers of biologics to "jump through all kinds of manufacturing andprocess hoops."

One section of the bill would require the FDA to spell out the reasonsfor putting a clinical hold on a study within 30 days of a request bythe sponsor of an investigational new drug application. Within thatsection there also is a provision authorizing a Phase I or II clinicaltrial after an accredited institution approved it and the FDA has beennotified.

A small company with one product in clinical trials can become"paralyzed" when the study is put on hold, Feldbaum said, oftentimeswithout the company knowing the reason.

Another provision calls for the FDA to publish, within one year,criteria spelling out the type and amount of information to beincluded in new drug and product license applications. The agencywould have to meet with a trial sponsor within 30 days of a requestregarding trial design and size. FDA advice that is in writing couldnot be changed after testing begins without a valid safetyconsideration.

HR 3199 also states, "When there is a high level of confidence in thescientific validity of the results of an adequate and well-controlledinvestigation, the `substantial evidence' required to demonstrateeffectiveness may consist of data from one such investigation andsupportive scientific evidence."

Also in the section on drug effectiveness, the FDA is required toconsider whether the benefits of the drug outweigh risks anduncertainties in the case of serious or life-threatening conditions.While approving such a drug, "FDA may seek agreement of thesponsor to conduct post-marketing studies."

A section of the bill on third-party reviews authorizes the FDA torequest review of all or part of an application by an accreditedperson, with concurrence of the sponsor. The FDA would have topublish requirements to accredit organizations and respond to anaccreditation request within 60 days.

The new bill would allow a new drug manufactured in a pilot or othersmall-scale facility to be used to gain approval prior to scale upunless the FDA can show product from a full-scale facility is neededbefore safety and effectiveness can be shown.

Manufacturing provisions in the rewritten bill contain languageagreed to between BIO and the FDA. The draft sets forth specificcircumstances in which manufacturing changes must be reported tothe FDA.

The bill also includes the "biologics rewrite" from the Senate bill,which would allow product license and establishment licenses to bemerged into one application.

"The main thing I'm concerned about is we won't have enough timeto enact this," Feldbaum said. "If we don't we'll come back next yearand enact it, no matter who is elected. If it is enacted we'll come backnext year and refine it." n

-- Jim Shrine

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

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