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FDA’s Risk Communication Advisory Committee has made several recommendations, said FDA Deputy Commissioner for Policy Randall Lutter in a column on the agency’s Web site. “The recommendations advise us to treat risk communication as a core activity and plan and provide resources to support it,” he said. “They advise us to take advantage of outside expertise to get the research we need so that our risk communications are grounded in scientific standards. They also advise us to develop a process to involve you – both the public and healthcare professionals - in deciding how we communicate with you.”

The agency has created an internal council charged with figuring out how to act on the recommendations, and how to make risk communication policies more consistent throughout the agency.

CDRH has proposed to stop requiring baseline reporting as part of device adverse-event reports because the information is also contained in MedWatch mandatory reporting forms.

The proposal is proceeding under a direct final rule unless an adverse public comment is received. In such a case, the proposal would move under a proposed final rule. The proposal may be accessed here.

– James G. Dickinson

CDRH has settled with a consumer group and has abandoned its position that dental mercury amalgams have every right to stay in the marketplace without a warning label.

The deal came three months after a settlement offer from Consumers for Dental Choice. The group had been trying for 10 years to get CDRH to require labels about the neurotoxic side effects of mercury amalgams.

In a news release, attorney Charles G. Brown for the group said: “During a several-hour negotiation session, FDA agreed to change its Web site on amalgam—dramatically.” He continued, “Gone, gone, gone are all of FDA’s claims that no science exists that amalgam is unsafe, or that other countries have acted for environmental reasons only, or that the 2006 scientific panel vote affirmed amalgam’s safety.”

Instead—see www.fda.gov/cdrh/consumer/amalgams.html—FDA has moved to a neutral course. Its new policy statement recognizes the serious health concerns posed by mercury amalgam, in particular for children and unborn children, pregnant women, and those with mercury immuno-sensitivity or high mercury body burdens.

Brown called the agency’s move “a 180-degree reversal from FDA’s 30-year policy of protecting mercury fillings…To change FDA policy, we tried petitions, congressional hearings, state law fact sheets, scientific advisory committee hearings, and letters galore—to no avail. So in the great American tradition, we sued.”

This led to judicial direction to mediate, and the agreement was forged May 30 before District of Columbia federal court magistrate judge John M. Facciola.

“The impact of the rewriting of [FDA’s] position on amalgam can hardly be understated,” Brown said. “FDA’s Web site will no longer be cited by the American Dental Association in public hearings. FDA shows awareness of the key issues involved. As it prepares to classify amalgam, FDA has moved to a position of neutrality. Indeed, having repeatedly raised the question of amalgam’s risk to children, young women, and immuno-sensitive persons on its Web site, I find it inconceivable that FDA will not in some way protect them in its upcoming rule.”

– James G. Dickinson

In a column on FDA’s Web site, Murray Lumpkin, MD, FDA’s deputy commissioner for international and special programs, reminds industry that one cannot extrapolate adult clinical data to make assumptions about how a medical product will work on children. Most of the column discusses drug dosages, but Lumpkin notes that legislation passed last fall expands efforts to help ensure that strong, science-based data are developed to guide the safe use of medicines in children to pediatric medical devices.

“FDA remains firmly dedicated to actively facilitating and fostering the development of sound data to guide the safest and most effective use of medicines and medical devices in our children,” he said. “Children are not little adults. They are not second-class citizens. They are not guinea pigs. They are our most precious gift. Children deserve medical care based on the best data science can give us.”

FDA on August 4 enacted a long-discussed policy that sets limits on how tied members of its advisory panels can be to the industries those panels deal with, reports TheHill.com. Experts may not participate on an advisory committee if they are a member of their immediate family have a stake of more than $50,000 in any companies who come before that panel. Those with stakes of less than $50,000 need a waiver from the agency in order to participate. The agency says it will grant a waiver only if it “determines that there is an essential need for the adviser’s particular expertise.”

Many experts recruited by FDA to serve on panels also consult for drug and device companies. This had led to criticism from some members of Congress and the public that the panels are biased in favor of industry.

The agency also implemented a rule that will make the materials for all panel meetings available to the public at least 48 hours before the meeting starts. And votes will now be conducted simultaneously, not sequentially, to prevent panelists from being influenced by the votes cast before theirs.

The Senate Appropriations Committee has passed a measure that would provide FDA with $2.04 billion in fiscal year 2009, an increase of $324.9 million from its initial appropriation last year. The agency expects to receive another $628 million from user fees. A House subcommittee passed a similar bill in June. The measures must now go before the full House and Senate.

FDA has announced that it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. The FDA Commissioner’s Fellowship Program will offer participants training in the scientific analysis needed to make safety and regulatory decisions.

The program will launch in October. Participants can be physicians, microbiologists, chemists, statisticians, pharmacists, biomedical engineers, nutritionists, veterinarians or other science professionals. Applicants should have a doctoral degree in medicine or another scientific field; engineers must have at least a bachelor’s degree. Between 30 and 40 applicants will be accepted for the first entering class. It is hoped that many of the participants will choose to have a career with FDA.

The agency needs an influx of highly skilled people with specialized and relevant expertise, and the program could be one way to get them, agency officials said.

Florida federal judge G. Kendall Sharp ruled against FDA on four out of five counts in U.S. v. Endotec Inc. It was the fifth consecutive federal court loss for the agency, spanning 17 years.

In Endotec, Sharp, a 1983 Reagan appointee, took the opportunity to lecture the agency that its “stringent regulations and strict interpretation of procedural requirements are resulting in technological innovation being stymied, rather than advanced.”

As in all of FDA’s other defeats, in Endotec the agency made no allegations of patient injuries from the challenged devices, or even likely safety risks. The judge emphasized this fact in his order.

The case involved CDRH charges that Endotec (South Orange, NJ) and its two principals—president and coowner Michael Pappas and vice president, medical director, and coowner Frederick Buechel—marketed unapproved, adulterated, and misbranded implantable devices.

The government sought a permanent injunction and an order of disgorgement. On the basis of several FDA inspections between 2001 and 2005, it charged that the company had shipped about 4000 devices when its investigational device exemption (IDE) allowed only 109 for clinical trials. (Endotec was unable to say how many devices were exported versus shipped domestically.) FDA also alleged shipments to physicians who were not enrolled in Endotec’s clinical studies, distribution of devices that differed from their approved design and did not have required labeling, and distribution “under the guise of the ‘custom device’ exemption…even though the devices did not qualify for such exemption,” among other violations.

The devices cited in FDA’s complaint were knee, ankle, and temporomandibular joint replacements. Endotec contended that its manufacture and distribution of these devices was at all times protected by the “custom device” or IDE provisions of FDA regulations. CDRH dental devices branch chief Mary Susan Runner acknowledged weaknesses in the government’s case against the firm.

Sharp’s decision follows four others—Utah Medical Products (2005), Andersen Products (1997), Laerdahl (1994), and BioClinical Systems (1988)—in which CDRH-sourced prosecutions have failed in federal court when contested. In each of these defeats, CDRH interpretations of regulatory terms and requirements figured prominently. In Endotec, Sharp found a definition of custom device by CDRH associate director for regulatory guidance and government affairs Casper Uldriks “so narrow as to make the definition useless.”

CDRH’s losing streak involves an enforcement policy that is reminiscent of the court battles its drugs counterpart, CDER, fought against the generic drug industry more than 20 years ago. Notably, in U.S. v. Barr Laboratories, the presiding judge became so exasperated with FDA’s interpretation of its archaic drug GMP regulations that he rewrote a large section of them.

Since those battles have faded from memory, CDER has adjusted to a new judicial climate. Federal judges are much less likely than before to defer to federal agencies’ interpretations absent evidence of actual harm to public well-being.

As I wrote in 1999, this judicial shift required FDA policymakers to collaborate more intimately with the Office of Chief Counsel in recrafting enforcement and compliance policies if they wished to avoid continuing reversals. CDER seems to have done this, but not CDRH. This intransigence was most recently seen in its civil case against TMJ Implants Inc.

The chief counsel seems to support both CDER’s and CDRH’s approaches, notwithstanding their apparent divergence. Perhaps this is evidence of an unintended consequence of an HHS General Counsel instruction issued in the Reagan era. It elevated the “lawyer-client” relationship between FDA and the chief counsel to a controlling ethic. Could it be that this move also spawned a “my client, right or wrong” advocacy mentality among FDA lawyers in place of the old, collegial collaborator’s role in designing the legally soundest policies?

A comment on the Web site www.fdaweb.com that could have come from an FDA enforcement official may shed some light on CDRH’s position. It stated that CDRH’s current policies are seen inside the center as having “been more than accommodating to the medical device industry. It gets kid-glove treatment compared with other industries. For example, the inspections are preannounced and 483s are annotated with the firm’s comments. For some years, FDA held off on issuing warning letters to device manufacturers to allow them time to respond to 483s and prevent issuance of such letters.”

The observer went on to say that these accommodations were implemented after “FDA had grassroots-level meetings with industry [stakeholders] to address their concerns about being regulated and their opposition to inspections and investigators. At that time, the industry group accused investigators of being renegades, when in fact they were only guilty of being competent and dedicated. It also griped about the lack of consis-tency in inspections and FDA responded by implementing the use of canned-language 483s.

“The QSRs [quality system regulations] were spearheaded within FDA by individuals with industry experience and in conjunction with industry. Industry had opportunities during rulemaking to comment on the QSRs,” the statement continued. “Seems like FDA has bent over backwards to coddle the industry, but they are still just not happy to be regulated. Instead of just complying with the regulations that were promulgated with their input, they still blame FDA for doing its job. They skewer the investigators and mock the attorneys.”

– James G. Dickinson

The software sleuths at FDA are no longer operating under cover. A recent article in the Baltimore Sun examined the issue. The reporter talked with FDA’s Larry Kessler and Brian Fitzgerald about the agency’s efforts to build up its forensic capabilities with the use of static analysis tools.

I normally avoid addressing a topic twice. I just talked about FDA’s move in this direction in the February issue of MD&DI. But the forensic software lab at FDA seems to be getting some legs. “This approach is gaining a lot of momentum, and it is probably not going to be turned back,” says David Vogel, PhD, founder and president of ­Intertech Engineering Associates in Westwood, MA.

The problem for medical device companies­—especially small firms—is that implementing static analysis programs can be costly. However, it is clear that the expectation for quality assurance in software engineering is here to stay, so it’s time to step up your game. Whether you should opt to implement your own static analysis tools or seek another method is open to debate.

“Good software engineering, which includes design controls, risk analysis, a quality system, and proper tools and techniques, is critical in reducing the likelihood of errors,” says Andrew Dallas, president of Full Spectrum Software (Southborough, MA).

Device companies must be increasingly vigilant about preventing software-coding errors. The question, however, is whether static analysis tools are the answer to eliminating the software-­coding errors.

“Static analysis tools have a place in software development engineering. But, they are not very productive, and I don’t think FDA should be forcing their use on industry,” says Vogel.

Dallas strongly believes in the value of static and dynamic analysis tools, but he adds, “I would stress that devices are not designed to make decisions but rather they are designed to require input from trained professionals. For instance, before treatment can be delivered, confirmation is required by the operator that the dosage is correct.”

He points out that software development is often looked at as a necessary evil to get hardware products to market. But software development takes talented, disciplined engineers with the right tools and training to produce the quality of software demanded for sophisticated medical devices.

Dallas notes that finding software defects is very much like detective work. “Perhaps it’s straightforward, but there are processes, protocols, and tools that we use to find defects. With multithreading, multiuser access, and real-time acquisition and control, defects can hide without discovery unless static and dynamic analysis tools are used.” Vogel disagrees. He says that static tools are hyped to do more than they can actually deliver. “Static analysis looks for simple coding errors and does not apply heuristics to understand how it will perform dynamically because it is a static analysis tool,” he says.

Industry is slow to adopt these tools because they are not great, explains Vogel, noting that they create more false-positive findings than true positives. “Industry’s limited resources are spent on more tried-and-tested methods that don’t waste resources documenting why false positives are false.” Unfortunately, the headline of the Sun article—no less than sensational journalism­—may amplify the problem. Its headline, “Flaws in Medical Coding Can Kill,” could create some unnecessary panic among consumers, and it seems the article was written to fulfill the headline’s premise.

Referring to a dialysis machine being investigated, Fitzgerald told the Sun, “We declared the software innocent.” Such a statement implies that FDA is taking its forensics role very seriously.

“Regulation in this area is much more prescriptive than it was 20 years ago, and the results haven’t improved,” says Vogel. “I don’t think more regulation and forced use of static analysis tools will make things better.”

Perhaps these tools—and FDA’s lab—are a solution in search of a problem. Nevertheless, the lab appears to be here to stay, and you need to be prepared for the fallout.

– Sherrie Conroy

The Office of Device Evaluation annual report released Monday shows that CDRH was much faster in reviewing PMAs in fiscal year 2006 than in FY 2005, Reuters reports. The report attributed the improvement — PMA reviews dropped from an average of 438 days in FY ‘05 to an average of 335 days in FY ‘06 — to reforms implemented from the Medical Device User Fee and Modernization Act of 2002. Statistics for FY 2007 are not yet available.

However, average 510(k) review time rose slightly, from 87 days in FY ‘05 to 95 days in FY ‘06. And the report also noted that third-party reviews dropped in 2007, compared to 2006. That was before reforms to the program included in the FDA Amendments Act of 2007 were implemented, though.

– From MD&DI’s blog.