WASHINGTON _ A House subcommittee launched its formalinvestigation of the FDA on Thursday with a hearing on medicaldevice regulation. Rep. Joe Barton (R-Texas), chairman of theCommerce Committee's subcommittee on Oversight andInvestigations, said more hearings scheduled for next month willscrutinize the agency's performance in other critical areas, includingdrug regulation.

Led by Speaker Newt Gingrich (R-Ga.), many House Republicanshave been openly critical of the FDA, calling for a fundamentalrestructuring of the agency. In an attempt to respond to the attacks,the Clinton administration swiftly tucked FDA reform under the wingof its "Reinventing Government" initiative and has promised toproduce a detailed plan for change in the next few weeks.

As a result, political fault lines in the debate over the FDA's mandateand performance are deepening along party lines, with Democratswaiting for the President's plan and Republicans insisting on moreradical change. The fractures were in evidence on Thursday.

"There have been assertions by certain groups that the FDA is thetarget of some kind of witch hunt," noted Barton at the start of thehearing. "I want to assure everyone that this investigation and thesehearings will be conducted in a fair and fact-finding manner."However, Barton added that FDA approval of new medicaltechnologies is "too slow, too expensive and too arbitrary" and thatthe agency has "lost its direction."

The House investigation, according to Barton, will focus on "realworld" testimony from people "who have tried to work with the FDAbut had trouble." But that recipe may produce no more than anabundance of anecdotes about FDA incompetence, seasoned by somespicy partisan rhetoric.

Just The Facts - No Cheap Rhetoric

In his opening statement, Rep. Henry Waxman (D-Calif.) counteredthat the subcommittee needs to act "on facts, not anecdotes," addingthat some of the "horror stories" told by FDA critics are "of dubiousveracity." Waxman's Democratic colleagues chimed in on this topic.

"Let this subcommittee reject the cheap rhetoric, ideological myth-making and half-baked anecdotes that have been peddledaggressively by powerful special interest groups since the Novemberelection," said Rep. Ron Wyden (D-Calif.). "Make no mistake aboutit; the agenda of these extremists who masquerade as reformers is totear down the FDA and give self-interested parties the keys to themedical kingdom."

Legislators then heard testimony from members of the public andexperts who claimed _ under oath, as is the custom in the Oversightand Investigations subcommittee _ that the FDA's slow reviewtimes for medical devices are strangling the $40 billion deviceindustry in the U.S., as well as harming patients.

For example, Glenn Sklar, of Columbia, Md., is the father of adiabetic toddler who must submit to a painful, finger-prick blood testevery four hours to manage the disease. He told subcommitteemembers that the FDA has been unfairly "sitting" on an approvalapplication for a non-invasive glucose monitoring device that couldspare his daughter significant pain and anguish.

Although no FDA officials were invited to the hearing, Barton saidhe was told the agency had questions about whether the product,called the Diasensor, was as accurate in measuring blood glucoselevels as the finger-prick method. "The word in the diabetescommunity is that the device is very, very accurate," said Sklar.

Biocontrol Technology Inc., the Pittsburgh-based manufacturer of theDiasensor, submitted a licensing application to FDA in January 1994and was asked to submit additional data last December. The agencyis still reviewing that data on the infrared light-based probe, which isdesigned to detect glucose through the skin.

Another witness, an Austin, Texas-based entrepreneur named AliGallagher, recounted how her start-up company, U.S. MedicalProducts Inc., had to be sold because of FDA delays in approving itsimplantable hip and knee devices. While she waited for FDAapproval, she sold products in Europe and was awarded the Exporterof the Year Award from her local Chamber of Commerce. Shortlythereafter, she was forced to lay off half the employees in hercompany.

Kessler Shoots Back At Critics

The House Commerce Committee isn't the only place where theFDA's role is being debated. On Tuesday, FDA commissioner DavidKessler testified before an Appropriations subcommittee on theagency's fiscal 1996 budget and faced some tough questions fromRepublicans. At one point, even the usually unflappable Kesslerappeared aggravated after Rep. Jack Kingston (R-Ga.) sharplycriticized the agency's record on device regulation.

"You don't think I want to get devices that are important to save livesout there? Who do you think works at the FDA? Real physicians whohave lost real patients," Kessler said.

Rep. Richard Durbin (D-Ill.) rushed to the FDA's defense atTuesday's hearing, portraying advocates of an FDA overhaul asgreed-inspired. "There's money to be made if the FDA can bedismantled," said Durbin, sounding an increasingly familiarDemocratic theme. "Behind these groups calling for reform we findthe regulated companies." He advised Kessler to "stand firm" againstthe "withering attacks" of critics.

For the biotechnology industry, the legislative cliff-hanger of the yearcould be whether changes at the FDA end up being moderate,profound or just a pipe dream. Paul Gigot, a conservative columnistat The Wall Street Journal and a commentator on TheMacNeil/Lehrer Newshour, offered a gloomy prediction at the annualmeeting of the Pharmaceutical Research and Manufacturers ofAmerica on Monday.

"As far as FDA reform goes, look for tinkering around the edges atthe most unless we see a massive change in public opinion," saidGigot. n

-- Lisa Piercey Washington Editor

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