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Originally published July, 1996

James G. Dickinson

Two opposing cultures collide whenever FDA and industry meet. Most of the time the impact is gentle, with each side respecting the other's difference. But occasionally the impact results in a real explosion.

And an explosion with aftershocks is what has come from what some see as an enviably close relationship forged by David Muller, CEO of Summit Technology, Inc. (Waltham, MA), between his ophthalmic laser manufacturing company and the Office of Device Evaluation (ODE) in FDA's Center for Devices and Radiological Health (CDRH).

At first, Muller may have seen little in the culture difference to lose sleep over. By now, however, he may have reflected on the downside of mixing too closely with FDA--nasty little consequences that, in an extreme case like the generic drug scandal, cost 6 FDA employees and nearly 20 industry executives jail time.

Summit's FDA aftershocks haven't risen to nearly that level, but they're pretty discomforting in terms of media headlines, drops in company stock prices, and in-depth investigations by both FDA's Office of Internal Affairs and the FBI.

While the situation falls short of the generic drug scandal, there is a common denominator: excellent FDA relations that some came to view as a little too excellent. According to some observers, Muller and his team learned to work the agency with a dexterity that baffled rivals and angered ophthalmologists who were subjected to FDA inspections that they attributed to Summit's influence at the agency (they were using reimported Summit lasers without paying royalties to Summit).

According to its trade and professional critics, including former Summit executives now employed by competitors, Summit and David Muller were able to use their FDA skills to build a dominant position in the fledgling U.S. excimer laser eye sur-gery market even before the company's devices were approved for that indication last year.

The company's winning streak only faltered at the end of last November, when the U.S. Postal Service brought to Muller's home an FDA envelope containing confidential agency documents about a still-pending excimer laser marketing application from rival Visx, Inc. (Santa Clara, CA). Included were a draft approval letter, engineering data, another competitor's data, and internal CDRH memoranda. The previous month, Summit's own corneal surgery laser had been approved for its second indication, so the package wasn't valuable for approval purposes. But some speculate that the data would have been very useful in Summit's ongoing patent litigation with Visx, as well as for a possible premarket approval (PMA) supplement to upgrade its approved product. While saying that he did not examine the materials closely (he returned them to FDA, says a company representative, within one business day of receiving them), Muller suggested to this writer that given Summit's technological lead over Visx, the materials could not have been helpful to his company.

Whatever its value to Summit, the packet's return launched both FDA and FBI investigations into all those effective connections Summit had evidently enjoyed at CDRH for at least two years. Close company and FDA observers of some of those connections say they seemed so friendly as to cross the conventional boundary separating official business from personal relations.

For example, Summit vice president for regulatory affairs Kim Doney is said to have regularly (some say even routinely) engaged in lengthy telephone conversations two or three times a day with the lead CDRH reviewer on Summit's pending PMA submission. Frequently, observers say, those conversations veered into nonbusiness subjects. Doney declined to comment to this writer about her FDA contacts, but, in an interview, Muller pulled no punches about the company's familiarity with CDRH people, stating that he has made himself well known to "everyone" in the ophthalmic devices and other divisions, both during numerous personal visits and over the telephone.

When does such rapport become too close and run the risk of unleashing a backlash against the company that cultivated it? That point may not yet have been reached in Summit's case. But some medical practitioners who have been using the company's earlier-model lasers claim that Summit had a way of getting FDA to do just what it wanted, even to the point of helping it build market domination. The ways Summit did this, they allege, include the following:

* Influencing FDA to issue an import alert last February on all previously exported Summit lasers so that ophthalmic surgeons couldn't buy them more cheaply overseas. Clinically, these surgeons say, most of the reimported devices are identical to the recently approved model, except that they lack a built-in procedure counter and a Summit-devised lockout device to block their use in a newer procedure known as photorefractive keratectomy (PRK). Both these add-ons are necessary to ensure that Summit collects $250 in royalties on each PRK procedure performed in the United States.

* Leading FDA to inspect practitioners who bought reimported lasers that don't carry royalty mechanisms and to cite them for investigational device exemption (IDE) violations or misbranding.

* Persuading FDA, in the terms of its approval of Summit's new laser, to limit PRK surgeries to devices approved for ablating corneal tissue in a 6-mm optical zone. All predecessor devices had approval only to 5 mm or less; until last April, when the Visx excimer laser was approved, only Summit's newest model had approval for 6 mm, effectively giving the company six months of competition-free marketing.

* Using its influence with FDA staffers to slow down the review of the Visx PRK laser.

According to former Summit western sales manager James C. Fallon, who has sued Summit for wrongful dismissal, these alleged actions were all part of a broader plan to gain a lock on the U.S. eye surgery laser market before FDA approval. Summit's strategy, he claims, was developed in 1990 and included selling upgradable holmium lasers (which have limited glaucoma indications) in anticipation of eventual FDA approval of the Summit device for more advanced phototherapeutic keratectomy (PTK) and PRK. Covered by 510(k)s, these holmium lasers were sold as "workstations" at six times the price of competitive holmium lasers, Fallon claims, because they could be easily and quickly upgraded after FDA approval. Ophthalmologists who did not buy early would be faced with postapproval delays of 12 to 18 months.

Fallon says he was fired for not accepting oral orders to participate in this alleged preselling scheme while the company was issuing written directives (for FDA's benefit) warning its sales team not to presell the unapproved lasers.

"Summit management practiced a web of deceit by instructing the sales force in writing not to promote, market, or sell the excimer laser," Fallon says in a declaration dated March 3, 1996. "Factually, Summit management including but not limited to J. Frantzis, Peter Litman, and David Muller himself put tremendous pressure to secure sales of the Summit laser, prior to its FDA approval. The sales force were told that Summit needed the cash flow to stay alive as it was hemorrhaging red ink, because of the delay in securing FDA approval."

Another Summit employee who was fired, former vice president of sales and marketing William Kelley, told this writer he was miserable the whole 10 months he was at Summit, mainly because Muller "dominated everything" and used questionable tactics, including the preselling of the excimer laser through the holmium workstation. "He's a power guy. He . . . pushes things to the limit. During the time I was there, he used the expression 'pushing the envelope.' I remember one time, regarding the FDA, he said we were going to go until we were nose-to-nose with them, and they would have to say 'Stop doing this' before we would stop doing some of the things we were doing and saying in terms of getting sales."

Kelley said Summit sold 80 to 100 holmium systems using the excimer sales carrot. "There were lots of commitments by sales reps and even the sales manager that 'You'll have the excimer head within six months of approval,' or 'You'll be the first one in line,' that sort of thing."

Amid a barrage of ophthalmologist and trade complaints extending over three years, FDA finally received something it couldn't ignore: a four-page purported internal Summit memo to Muller dated July 11, 1990, describing the scheme. This moved CDRH compliance director Lillian J. Gill to send Summit a warning letter that was followed by an eight-day inspection in January 1995. The resulting FDA-483 notice made no mention of preselling, however, merely citing Summit for inadequate rework documentation, use of an obsolete test data sheet, and failure to calibrate a digital thermometer, observations to which Summit readily consented.

Not all the sales during this preapproval period were of the holmium workstation, according to Fallon. In a memo dated December 15, 1995, to pioneering laser surgery ophthalmologist William Ellis, MD, he named four such purchases, with the handwritten notation: "The physicians above bought [the] excimer laser before approval! I'm not talking about workstations but actual lasers."

Some ophthalmologists balked at paying up to $380,000 for a $60,000 holmium laser with upgrade commitments from Summit. An estimated 30 to 40 bought exported and foreign-built Summit lasers overseas and in Canada for a fraction of the U.S. price, and began using them immediately as "investigational" or "custom" devices exempt from FDA interference. Eventually, however, FDA began interfering, allegedly at Summit's behest, sending "adulteration/misbranding" warning letters to Ellis and several others, even though these devices were clinically identical to the lasers Summit used in its U.S. clinical trials to gain approval for the PTK and PRK indications. According to Ellis (also now in litigation with Summit) and others, the only difference between the various models is that Summit's postapproval models have counters and card-reading lockout attachments for assessing per-procedure royalties due. There is another difference, however--Summit is now refusing to service the reimported devices, or to provide operating manuals.

When I asked Summit's David Muller what made the reimported Summit devices clinically different, he seemed unsure. While acknowledging that "the counter has no clinical effect," he insisted that "there's a whole variety of things that could have a clin-ical effect." Asked to elaborate on the differences, he declined, other than to say that the imported devices can "treat patients over a much larger range of treatment parameters" than the FDA-approved models.

When I asked ODE director Susan Alpert about the clinical differences and the justification for the import alert, she said that the imported devices did not bear current approved labeling and that the PRK lockout feature could have some clinical significance, although she could not discuss that. Informed that Ellis and others claimed they could not obtain copies of the approved labeling in order to bring their machines into compliance, Alpert said: "The labeling is FOI-able." Ophthalmologist Ellis, however, told me later that he has been unable to get final labeling from the agency, despite filing a Freedom of Information Act request for it last December.

Ellis has also raised the issue of the Summit device's safety, claiming that its 6-mm beam width releases too much energy in the eye and can cause retinal detachments, as reported by overseas clinicians. Muller denied this, pointing to an absence of such reports in the company's data used to gain approval: Why would these be popping up overseas, and then only in isolated instances, while hundreds of U.S. case reports cleared by FDA are free of such implications?

Alpert said she believes the overseas reports result from improper patient selection; some people are by medical condition predisposed to retinal detachments and should be screened out before being subjected to 6-mm PRK surgery.

Ellis has a darker suggestion. Thirty of Summit's total of 89 U.S. case reports with the 6-mm beam involved young, mostly male naval recruits in San Diego who are not representative of the surgery's patient population overall, and who have a natural ability to "accommodate" the overcorrection of the Summit PRK device, he said. When they reach their 40s, these subjects will likely have weak vision attributable to the procedure, he claimed. As for all the other case studies submitted by Summit, Ellis claimed they were done in England using different software.

Summit, however, strongly denied that any of its studies were foreign. In a recent letter, Summit attorney William Lee declared that "all of the data submitted by Summit to obtain FDA approval was from standardized, multicenter clinical trials in the U.S."

On other aspects of the controversy, Alpert declined to comment, in view of the current Office of Internal Affairs investigation into the leak of confidential documents. She did say, however, that her office has increased document security since the leak, through intensified employee training and the addition of locks to offices and desks that contain sensitive documents. In a separate conversation, again constrained by the investigation, CDRH director Bruce Burlington admitted that the new security measures might result in slower reviews by impeding the previous "flexibility" that reviewers enjoyed.

Neither official would acknowledge that Summit may have had "too much" familiarity with their employees. That, after all, is what the investigation is all about.

James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.

SUMMIT RESPONDS

In response to MD&DI's request for an interview with a company official, Summit Technology provided a written statement through a Washington, DC, public relations firm, Apco Associates. In a preface to the following questions and answers, the statement included a comment that two of the sources, William Ellis and James Fallon, quoted in the accompanying Washington Wrap-Up article, "have been involved in litigation against Summit." According to the statement, "both have a vested interest in the spread of misinformation about the company." The statement did not identify specific elements of such alleged misinformation.

What was Summit's role, if any, in FDA's February import alert on previously exported lasers, and what role did Summit play in FDA's decision to inspect practitioners who purchased these lasers?

Summit has no influence or role in FDA's decision-making processes. Importation of unapproved devices has been a concern for FDA throughout its review of this technology. As a result, per the approval letter Summit received from FDA with respect to PRK, Summit is required by the agency to report anyone using gray market equipment. The specific language in that letter is as follows:

In addition to the postapproval requirements . . . , the following information must also be submitted to the Agency:

4. reports to FDA CDRH's Office of Compliance at the address below of any instances of device tampering or usage outside of the approved indications, and any excimer systems that were exported under a 801(e) order and are now back in the U.S.

In compliance with that regulatory requirement, Summit reported information to FDA as requested in the above paragraph.

Did Summit sell upgradable holmium laser workstations that could be upgraded with excimer lasers?

Summit has always complied with FDA's commercialization rules and, as part of that compliance, the company never presold any excimer lasers. Our efforts to prevent commercialization of excimer lasers was extensive. All of Summit's quotations and invoices, which physicians were required to sign before purchasing the product, bore the following legend, or one similar to it:

This system contains only a holmium laser, not an excimer laser. Purchase of this system does not entitle the purchaser to purchase, use, license or otherwise benefit from any excimer laser, which currently is an investigational device under applicable FDA regulations.

While Summit never promised or presold excimer lasers as part of the holmium workstation package, it was clear that the holmium workstations were designed to accommodate excimer lasers in the event that (i) excimer lasers received FDA approval and (ii) physicians purchased such lasers in the future.

Did Summit ever sell any excimer lasers before they were approved?

Excimer lasers sold by the company prior to approval for use in the United States were only sold to legitimate IDE sites or animal research centers. As permitted by the U.S. export laws, Summit also sold excimer lasers to parties for use outside the United States.

Was there a 1994 warning letter from FDA in response to an internal memo about sales strategies? Was the memo real or fake?

No. The obviousness of the forgery was blatant, and the purported author provided an affidavit that he did not write it. Any assertion to the contrary is simply false.

FDA paid considerable attention to the erroneous allegations made that Summit was preselling excimer lasers in violation of the commercialization rules. In fact, FDA sent a warning letter to Summit on that topic, citing erroneous reports. Summit addressed each incident in great detail and to FDA's satisfaction. The company demonstrated that the only excimer lasers sold prior to U.S. approval were sold to legitimate IDE sites or animal research centers.