Originally published December 1996
James G. Dickinson
Even as it escaped reform legislation that would have removed some of its fingers from the medical device regulation pie, FDA in September seemed headed for public disgrace on two device issues: over-the-counter substance-abuse test kits and ophthalmic excimer laser approvals.
Barely two months before the November elections, both issues made fine campaign fodder. The first set the federal bureaucracy against parents of teenagers everywhere; the second, in the words of an Investors' Business Daily headline, portrayed the bumbling "national nanny" as the witless tool of "senatorial privilege."
The adjourning Republican Congress was quick to take note. It staged a highly publicized hearing on the test kits issue and expanded its investigation of "lasergate" to include the alleged influence of Summit Technology, Inc. (Waltham, MA), on the approval process. Summit had made numerous and sizable donations to Senator Edward M. Kennedy's (DMA) reelection campaign in 1992. Previously, Congressman Joe Barton's (RTX) oversight and investigations subcommittee had been interested only in whether FDA had leaked laser documents from competitor Visx (Santa Clara, CA) to Summit last October.
The test kits issue centered around an FDA warning letter sent to Sunny Cloud, head of Atlanta-based Parent's Alert. The letter accused the group of distributing a misbranded and adulterated Class III medical device--to wit, a plastic cup, jar, and mailing label to a licensed lab. Parent's Alert had sold the kits, at a price of $40 each, to about 1000 customers, presumably parents wanting to know whether their teenagers had been abusing il-legal drugs.
When she was visited by the FDA investigator, Cloud recalls, she was at first flattered that her organization's good work seemed to be receiving federal recognition. The warning letter's arrival a month later quickly shattered that illusion. Cloud turned to the maker of Alcoscreen, a home test for alcohol, for help. The company, which had also received a warning letter and was in deep regula-tory trouble with FDA, referred Cloud to well-known device attorney Larry R. Pilot of McKenna and Cuneo (Washington, DC). Pilot not only wrote FDA a formal response to the warning letter, but also made several unreturned calls to Center for Devices and Radiological Health (CDRH) director Bruce Burlington on Cloud's behalf.
FDA had classified Cloud's kits as medical devices on the basis of their use in detecting "other conditions" besides diseases. But as former director of compliance in CDRH's predecessor, the Bureau of Medical Devices, Pilot had actually been present when FDA inserted the phrase "other conditions" into the 1976 Medical Device Amendments. It appears in the second statutory definition of a regulated medical device, in the phrase "intended for use in the diagnosis of disease or other conditions."
According to Pilot, the "other conditions" that the amendments' framers intended to address were only medical conditions, such as pregnancy. In fact, he says, the phrase "other conditions" was added specifically to embrace over-the-counter pregnancy test kits, which were controversial at the time. Unfortunately, neither the amendment nor its accompanying committee reports actually spelled out this important limitation. Of course, bureaucracies tend to expand definitions not completely spelled out when doing so can increase their power.
Since at least the mid-1980s, FDA has been expanding the definition of "other conditions." FDA closed down a Virginia diagnostics manufacturer that was selling home test kits for drug detection on the grounds that the products were medical devices lacking assurance of effectiveness. In 1987, FDA prepared a "points-to-consider" document for home-use in vitro diagnostic kits that declared that the center would evaluate such products' benefits and impact on society as well as patients. FDA's attempts to evaluate the societal impact of products may have caused much of the current dissatisfaction with the agency's performance.
This was certainly true of Commerce Committee chairman Thomas Bliley (RVA). At a congressional hearing on September 26 on the issue of drugs-of-abuse home test kits, Bliley raged at the agency's behavior regarding a dispute with Psychemedics Corp. (Boston), a supplier of such tests. During that dispute, FDA had said its jurisdiction extended to "family discord" caused by a test's use.
CDRH director of compliance Lillian Gill faxed a letter to Pilot on the morning of the hearing confirming that the agency deemed Cloud's "device" to be adulterated and misbranded. This letter caused a sensation when Pilot faxed it to the still-sitting subcommittee that afternoon.
FDA's position at the hearing, held by Barton's subcommittee, was particularly inexplicable given that five months earlier it had been forced to back out of the Psychemedics lawsuit. Burlington had acknowledged at the time that FDA's position would lead to certain defeat in the suit.
In comments made at a press conference the day after the September 26 hearing, Bliley said, "I am so angry I can barely contain myself."
Bliley said that FDA showed "a gross display of contempt for American parents." For example, Bliley said, "One witness, the FDA's Dr. Steven Gutman, went so far as to suggest that American parents are not competent to draw a urine sample from their own children, put it in a jar, mail it off to a lab, and then deal in a responsible manner with the results. 'I can deal with the results with my own child,' Dr. Gutman told us, 'but after all, I'm a doctor. I've got the benefit of two volumes of federal regulations on drug testing.' In 15 years in Congress, I don't believe I've ever heard the audience break into spontaneous boos and laughter at government witnesses."
Bliley continued, "Yesterday, they had to be warned five times to stop. They were right to laugh. They were right to boo. I'm right to be angry. And every American ought to know the story, and see that hearing. An arrogant, insulting policy based on a contemptible view of the American people. Washington know-it-alls who think we're not smart enough to handle and discipline our own children."
Bliley demanded a list of all those in the Clinton administration who had had any part in FDA's testimony. Congressman Christopher Cox (RCA) went further, demanding the resignation of Commissioner David A. Kessler. Democrats also joined in the criticism of FDA.
That same day, September 27, Burlington sent a two-page written apology to the subcommittee. In the letter, he reaffirmed his testimony that "the agency will expeditiously review our policy governing these products, including convening a public advisory committee meeting to reexamine the factors that are appropriate as a basis for marketing home test kits for drug abuse. Moreover, the agency has decided that it will defer any further regulatory action against Parent's Alert pursuant to the warning letter dated June 15, 1995, until the policy review we are undertaking has been completed."
Then came lasergate's latest episode, in the form of a report on the first page of Investor's Business Daily, September 30, with the headline, "Senatorial Privilege at the FDA? Kennedy Campaign Donor Gets Speedy Approval." Just when FDA's crisis-management team was hoping the laser approvals issue had died down, it was back in mainstream media headlines, and the congressional investigation into the document leaks to Summit had widened to include the Kennedy angle.
The newspaper's coverage included most of what had already been reported in trade publications and other media. The coverage also added more detail about the number and scope of Summit Technology contributions made to both the Kennedy reelection campaign and the Democratic National Committee during the FDA review of Summit's excimer laser. The newspaper reported that in addition to 17 donations in 1994 and 24 in 1995, when the device finally received approval, eight top Summit officials attended a postapproval Kennedy fund-raiser and "wrote checks to Kennedy's reelection campaign for 1994 to help retire the campaign's debt." Former Summit CEO David Muller reportedly "pitched in an extra $1000 toward Kennedy's year 2000 campaign."
The report echoed the implication made in a nationwide satellite television broadcast on September 5 by conservative National Endowment Television (NET) investigative reporters. The NET reporters had implied that FDA's approval of the Summit device was corrupted by Kennedy's political influence and the improper relationship between FDA and Summit.
CDRH's Burlington labeled the charges "utter fantasy." He said that "the idea that Senator Kennedy did anything that affected the approval is just stunning. I can't believe that that happened."
This assertion has been repeated even more fervently by higher FDA officials, who do not wish to be quoted for fear of giving the charges even a hint of credibility. But the ongoing FBI investigation on the leakage by FDA of Visx laser documents to Summit and the widening of Barton's investigation into alleged political influence strongly suggest that the charges cannot be dismissed so easily.
We're sure to hear more.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.