WASHINGTON _ Senate Labor and Human ResourcesCommittee Chairwoman Nancy Kassebaum (R-Kan.)introduced FDA reform legislation (S. 1477) that is beingexamined warily by members of the Senate and the drugindustry alike.
Kassebaum last August circulated a set of principles thatincorporated many industry suggestions for reform. (SeeBioWorld Today, Aug. 9, 1995, p. 1.)
Kassebaum introduced her bill without any co-sponsors,another signal that she has still not built a consensus onthe committee, said Carl Feldbaum, president of theBiotechnology Industry Organization.
Feldbaum is waiting to see if Sens. Thomas Frist (R-Tenn.) and Barbara Mikulski (D-Md.) sign on as co-sponsors, validating Kassebaum's bill as a moderateapproach to FDA reform. But both Senators are taking a"wait-and-see" approach, withholding their endorsementuntil the issues are laid out in hearings planned for earlynext year, according to spokesmen for each Senator.
Frist and Sen. Connie Mack (R-Fla.) have introducedlegislation sought by the drug industry to curtail theFDA's authority over promotional material. AndMikulski has championed the interests of biotechmanufacturers that are plentiful in the Washingtonsuburbs she represents. Mikulski was a prime moverbehind the White House's recent announcement of keyadministrative reforms that reduced many costlyregulatory requirements on biotech manufacturers. (SeeBioWorld Today, November 10, 1995, p. 1.)
Still not making known his position on FDA reformpublic is Sen. Edward Kennedy (D-Mass.) who also wasinstrumental in facilitating BIO's new-found dialoguewith FDA Commissioner David Kessler. (See BioWorldToday, Nov. 28, 1995, p. 1.) Kennedy often hascollaborated with Kassebaum on various types oflegislation but remains uncommitted on FDA reform.
`Imperfect But Acceptable'
Feldbaum said BIO has embraced Kassebaum's bill as an"imperfect but acceptable" vehicle to attain FDA reform.BIO is disappointed that Kassebaum "watered down" twoBIO proposals to establish FDA's sole responsibility overgene therapy research and the acceptability of a singlepivotal trial as evidence of safety and efficacy. "It is verylate in the day to be looking for a perfect legislativevehicle. Right now we hope that Kassebaum will get theright combination of supporters from members of thecommittee to address our concerns," said Feldbaum.
Support of trade associations representing the medicalproducts industry is critical if Kassebaum's bill is toadvance through the committee process. The HealthIndustry Manufacturers Association (HIMA) whoseagenda to make sweeping changes in the regulation ofmedical devices has found considerable support amongconservative Republicans, gave limited support toKassebaum's bill. HIMA wants tougher language to makethe FDA complete its review process on time, accordingto the association.
Kassebaum's bill was introduced when thePharmaceutical Research and Manufacturers of America(PhRMA) lost its top two lobbyists. Lynda Nersesianresigned last month complaining of harassment at theassociation. On Thursday, executive vice president andchief lobbyist Steve Conafay resigned after it becameclear that Conafay had lost the confidence of the PhRMAboard to be tapped to succeed association presidentGerald Mossinghof who is stepping down next year,according to industry sources.
Action on Kassebaum's bill is expected to begin inJanuary about the same time that House CommerceCommittee Chairman Tom Bliley (R-Va.) promised thathis panel will begin hearings.
Upon introducing her bill, Kassebaum said the legislationwas necessary "because over the years the agency'srequirements for clinical testing and its premarketreviews of new products have grown increasinglycomplex, time consuming and expensive. Today it takesan average of 12 years and costs $359 million to bring anew drug to market," said Kassebaum.
* Instructs FDA advisory committees and the agency notto include in an evaluation of a new drug any informationregarding relative effectiveness unless the effectivenessof the product is explicitly compared to that of anotherproduct in the labeling; any potential use not explicitlyincluded in the labeling; nor cost-effectiveness; or clinicaloutcomes.
* Permits manufacturers who have drugs in Phase IIItesting to make these products available to patients withlife-threatening disease "when the risk from the product isnot greater than the risk of the condition."
* Permits the FDA to contract with outside private revieworganizations for the evaluation of all or part of the newproduct application. This section also clarifies thatprescription drug user fee revenues may be used forexpert reviews by outside organizations and individuals.
* Requires the FDA to develop performance standards forthe review of new drug applications in order to expeditethe marketing of drugs used to treat life-threateningillnesses. Kassebaum's goal is to bring the FDA intocompliance with current federal law which now requiresthat it act on new drug applications within 180 days.
* Manufacturers may begin clinical research on newdrugs 30 days after the FDA receives notification fromthe sponsor containing the necessary safety data.
* Establishes that a single well-controlled clinical trialmay be sufficient "in many cases" to demonstrate safetyand efficacy.
* Permits biotech manufacturers to use pilot and small-scale manufacturing facilities to produce drugs andbiologics for clinical trial use.
* Allows biotech manufacturers to make minor changesin manufacturing without seeking prior approval from theFDA as long as the changes are validated by themanufacturer and records are made available to the FDAduring inspections.
* Regulates most biotech products as drugs, replacing therequirement for a separate establishment license with thegood manufacturing practices regulations now applicableto drugs.
* Requires the FDA to issue a new regulatory proposalfor new and emerging human tissue technologies. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.