WASHINGTON _ The American public is not aware that currentproposals to "reform" the FDA would roll back public healthprotections that have been in place for nearly a century, chargedThomas Moore, a senior fellow at the Center for Health PolicyResearch, at George Washington University.
"The penny hasn't dropped on how much we have at stake," Mooresaid.
In an editorial column that appeared in the March 10, 1996,Washington Post, Moore charged that Congressional Republicansand the pharmaceutical industry would cripple the FDA reviewprocess.
Moore attributed the conservative Republicans' interest in FDAreform legislation to "an atmosphere among them that the industrycan do no wrong, that it's time to get the government out of the wayof industry."
"Apparently Congressional Republicans believe the free marketplaceis adequate to protect the public," Moore told BioWorld Today. "Butthat doesn't recognize the fact that the current incentives on industryare to do as little drug testing as possible in order to keep researchand development cost down."
Moore said his warnings take on new urgency because of signs thatthe Senate Republican leadership is intent on moving the FDA reformbill as soon as possible. Sen. Nancy Kassebaum's (R-Kan.) SenateLabor and Human Resources Committee on Thursday will beginmarking up her proposal.
Moore said he was perplexed, as are several Washington insiders,about the lack of progress in the House Commerce Committee toeven introduce a bill. Moore, who testified last month atKassebaum's hearing, said he has cast his lot with those whospeculate that House Commerce Committee Chairman Tom Bliley(R-Va.) will introduce a controversial bill that will be pushed througha quick committee mark-up, and then rushed to the House floor inorder to minimize the uproar that would ensue.
How strenuously the White House will oppose Bliley and Kassebaummay be a function of Presidential politics not just drug safety, Moorecautioned. He pointed out that while FDA Commissioner DavidKessler last month testified in opposition to most of the provisions ofKassebaum's bill (see BioWorld Today, Feb. 23, 1996, p. 1), it ispremature for the White House to take a strong stand against the bill.
Greg Simon, an aide to Vice President Al Gore and the point man forthe White House on FDA reform, hedged his bets on when the WhiteHouse would fully declare itself on FDA reform. "First, we need tosee how Kassebaum has changed her bill. In the meantime, Kesslerdrew a good line at the hearings last month when he said that therewere areas where we could do better but that we had to start from thepoint that the FDA must protect the public health."
Simon stressed, however, that the administration is not totallyopposed to the Kassebaum bill. "We are open to productive ideas onreform," he told BioWorld Today.
Moore had hoped for a more activist stand from the administration."What Kessler should be doing is explaining how the FDA isprotecting the American public with its stringent drug testingpolicies," Moore said.
Moore vouched that Kessler has the support of the White House,noting that each time he testifies his statement is cleared by the Officeof Management and Budget and White House officials.
Moore said he was dumbfounded that a debate involving suchimportant public health issues has been so narrowly defined. "Thepharmaceutical industry is advancing the theme that the legislationwould cut development costs. There are several radio advertisementsdominating the Washington airwaves claiming that cancer patientsare being denied access to treatments."
Moore complained of what he called "apathy" among the Democraticmembers of the House Commerce committee, which has relied onRep. Henry Waxman (D-Calif.) to serve as a counter weight to moreconservative Republicans.
Biotechnology Industry Organization (BIO) President Carl Feldbaumdistanced himself from Moore's assertion that conservativeRepublicans and the drug industry are in agreement on FDA reform."We would do nothing to reduce clinical testing requirements."Feldbaum argued that Moore's article has "smudged the facts" andcontributes to the "political spin meistering so common in aPresidential election year."
Moore asserted that if the FDA steps back from its role to vouch-safethe purity and safety of a pharmaceutical, most of the risk will betransferred to physicians. "We haven't heard the voice of organizedmedicine on the legislation. Physicians need to think long and hardabout whether their lives will be made easier or harder to prescribetherapies that have been approved with less testing."
The marketplace also is an imperfect place to evaluate a new drugbecause the benefits and risk of a new product cannot be evaluatedwithout testing. In some cases, only long-term clinical testing withinthe population at large yields information about a drug's unintendedside effects. Moore used the example of calcium channel blockerswhich only last year were identified in three studies to have causedheart attacks instead of preventing them. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.