MOST VIEW FDA `FAVORABLY,'BUT SAY LENGTHY APPROVALS COST MONEY _ ANDLIVES
By Lisa PierceyWashington Editor
WASHINGTON _ While a majority of 1,000 Americans polled in arecent survey have a "favorable" opinion of the FDA, 76 percent ofthem said they believe the length of the regulatory approval processadds to the cost of drugs and 68 percent agreed with a statement thatthe process costs lives "by forcing people with incurable diseases togo without potentially beneficial drugs."
Rep. Joe Barton (R-Texas), new chair of the House CommerceCommittee's Oversight and Investigation Subcommittee, presided ata news conference announcing the survey results and said he was sodisturbed by the findings that he will likely hold hearings on theFDA's use of resources and approval times this spring.
"Americans understand that federal bureaucracy has grown out ofcontrol," said Barton. "They believe it has reached the point that itcannot perform some basic functions. This poll shows thatAmericans are especially eager to eliminate bureaucracy potentiallyhurting their health."
Hearings on FDA approval times will be nothing new for theOversight subcommittee: former chairman John Dingell (D-Mich.)held them regularly. "It's not going to be a witch-hunt against theFDA," Barton said of the planned hearing. "This is not one of theagencies being targeted for abolition." He added that he does notcurrently support privatizing the agency or ousting commissionerDavid Kessler. "I'm looking more at systematic changes and perhapspolicy changes," he told reporters.
The poll on public attitudes toward the FDA found that 65 percent ofsurvey respondents disagreed with the statement that the agency is"quick and efficient" and 67 percent believed that the time and cost ittakes for drugs and medical devices to gain FDA approval"discourages the invention of new, potentially life-saving products."(For more detailed poll results, see chart on page 5.)
Commissioned by the conservative, pro-business Citizens for aSound Economy Foundation (CSE Foundation), the poll wasconducted by Luntz Research Companies of Arlington, Va. LuntzResearch is headed by Frank Luntz, a pollster who has close ties toHouse Speaker Newt Gingrich (R-Ga.) and who test-marketed theContract with America before it was introduced by Republicans lastfall. (Luntz also worked for failed presidential candidates Ross Perotand Pat Buchanan.)
Polling experts warned on Thursday that it's hazardous to interpretresults from a study examining an issue _ such as the FDA and thedrug approval process _ that the average person knows nothingabout. "The problem with such a survey is that most peopleanswering the questions are uninformed," Stanley Pressler, an expertin survey methodology at the University of Maryland and a pastpresident of the American Association for Public Opinion Research,told BioWorld.
"One doesn't know if one should give any credence at all to theattitudes of uninformed people. I'd be very leary of drawing anysweeping conclusions about the public's attitude based on such asurvey."
CSE Foundation spokesman Brent Bahler said his group conducted afocus group (using 12 "scientifically selected" individuals inPennsylvania) in order to aim questions at the appropriate knowledgelevel. "We're very comfortable with the results," he said. LuntzResearch's corporate counsel, Kelly Anne Fitzpatrick, told BioWorldthat her firm strives to create "response neutral" questions forsurveys. "The client does have final say on the questionnaire becausethey own it," she added.
The CSE Foundation is the non-profit arm of themembership/advocacy organization, Citizens for a Sound Economy.According to financial statements, CSE and CSE Foundationcombined took in $7.9 million last year from about 250,000undisclosed contributors. CSE gets about 50 percent of its financialsupport from corporations while the CSE Foundation gets 27 percentfrom corporations and 63 percent from foundations.
Although some conservative groups (and Wall Street Journaleditorials) have recently called for the dismissal of Kessler andGingrich has called him a "thug and a bully," Barton said onThursday that it was premature to speculate on personnel changes atthe FDA. He appeared to distance himself slightly from Gingrich'sviews on Thursday. "I'm a good friend of the speaker and a loyalsupporter but I am the chairman of the Oversight and InvestigationsSubcommittee," Barton told reporters.
A plethora of think tanks in the nation's capital are working on FDAreform, including the Progress and Freedom Foundation (PFF), theconserative Washington policy group most closely allied withGingrich. (A large share of its $1.6 million annual budget goes topay for distribution of Gingrich's college course, called "RenewingAmerican Civilization," and to his cable TV show.)
According to the Wall Street Journal, the PFF plans to spend fouryears and $500,000 on its FDA reform effort, called the "MedicalInnovation Project," to achieve "a complete transformation of thetesting and certification process for medical technologies." WhenPFF disclosed its financial contributors last month, numerouspharmaceutical companies appeared on the list as well as onebiotechnology firm, Cambridge, Mass.-based Genzyme Corp.
Lisa Raines, Genzyme's vice president of government relations, saidthe company's contribution to the group was small ($5,000) andrepresents an attempt merely "to get a pipeline into Republicanthinking on issues that affect us." Raines said that Genzyme is "notinterested in tearing the FDA down" but wants to "take a goodagency and make it better."
Other conservative groups working on FDA reform include theWashington Legal Foundation (which has launched a printadvertising campaign using the advertisement featured on page A12of Thursday's Wall Street Journal), the Cato Institute, and theCompetitive Enterprise Institute. Next week, the PharmaceuticalResearch and Manufacturers of America plans to enter the fray witha news conference on the FDA's "biotechnology drug approvalprocess." The featured speaker will be George Rathmann, presidentand CEO of ICOS Corp., of Bothell, Wash.
FDA spokesman Jim O'Hara said that the FDA's latest report on thePrescription Drug User Fee Act shows that the agency has decreasedits backlog of overdue applications and is meeting all statutorydeadlines. "I'm not sure why they aren't recognizing the facts," hesaid of the numerous think tanks that are assailing drug approvaltimelines.
"The agency has consistently been looking at ways to improve itsperformance," O'Hara told BioWorld. "We understand, and haveunderstood for a number of years, that there are improvements thatcould and should be made. If anyone has good ideas about how to dothings better, we want to hear them." n
(c) 1997 American Health Consultants. All rights reserved.