Originally Published MDDI September 2004
Some worry that FDA's chief counsel is too eager to involve the agency in legal proceedings dealing with product liability damages.
James G. Dickinson
Risk-Based Bioresearch Monitoring Change | Sponsor-Monitor Reports Can't Be Shielded from FDA | Patient Lifts in Trouble | Eye Laser Recalled | Alternative Premarket Procedures Extended | Guidance on Export Certificates | Medical Leeches Are Devices
Since he joined FDA in August 2001, chief counsel Daniel E. Troy has never been far from controversy. First, it was for causing a major reduction in the number of warning letters the agency issues. This happened after regulated companies complained about them to FDA's parent Department of Health and Human Services.
Most recently, watchdogs have criticized his readiness to inject FDA into the state-court defense cases of FDA-regulated companies sued for product liability damages. Publicly, Troy has spoken little about this. But he has said that FDA's role in such cases is to uphold the agency's legal dominance rather than to comfort industry defendants.
In July, his latest critic, five-term congressman Maurice Hinchey (D-NY), added a monetary penalty against FDA for Troy's behavior. Hinchey accused the chief counsel of taking his FDA office in a “wholly unprecedented direction.” The congressman inserted an amendment in the agency's budget that passed overwhelmingly in the House. Under the amendment, $500,000 was removed from the commissioner's budget and placed in the Center for Drug Evaluation and Research budget instead. Why? Because, Hinchey said, the commissioner's office had obstructed Hinchey's staff in their efforts to investigate Troy's activities.
“The mission of the Food and Drug Administration is to ensure that the public is protected from unsafe food, drugs, and other medical products,” Hinchey told a press conference. “Daniel Troy is instead making it the agency's mission to protect…companies from being held accountable when their products do serious harm. This is not merely a question of financial compensation for the victims and their families. Civil action is a vital tool in gaining information about medical products and protecting future users of those products. Mr. Troy is trying to take that tool away from the public his agency is supposed to protect.”
Hinchey said he had learned of at least four separate cases that support his allegations. In these cases, Troy's office submitted briefs supporting the defendant corporation against the families of people who died after using that corporation's product. In three of those cases, Hinchey said, he found evidence of inappropriate collusion or conflict of interest between Troy and the defendant companies.
In one case, Motus v. Pfizer, Hinchey said Troy was advocating on behalf of Pfizer. The company had paid $360,000 for Troy's legal services the year he accepted the FDA chief counsel position. In another, Murphree v. Pacesetter, Hinchey said evidence showed that the defendant's lawyer was directing FDA on how best to intervene. In the third case, Dowhal v. SmithKline Beecham Consumer Healthcare, Troy met with the defendant's lawyer before filing a brief, Hinchey said. “In none of the four cases did the court request an opinion from the FDA,” a news release said. “This unsolicited insinuation into state civil suits represents a radical departure from the FDA's established practices, a fact Troy and the FDA have tried to obscure.”
In March, at an Agriculture Appropriations Subcommittee hearing, Hinchey said he questioned FDA acting commissioner Lester Crawford about Troy's actions. “The FDA's response was intentionally misleading,” Hinchey's release said. This led the committee to “adopt legislative language written by Hinchey expressing concern about the agency's credibility.”
In a statement on FDA's Web site, Crawford responded to Hinchey's charges: “Daniel E. Troy is a dedicated and talented public servant who has provided excellent legal advice to FDA since his appointment in August 2001. He fully complied with the ethical requirement to recuse himself from any matter involving a past client for a year after beginning work in the public sector. FDA has accurately reported the scope and nature of Dan's private- sector work. Any allegation that he has not conducted himself in compliance with applicable legal and ethical rules is simply false. Dan has my utmost confidence, as well as my heartfelt gratitude, for his steadfast leadership and wise counsel during this important period in FDA's history.”
In May, former FDA chief counsel Peter Barton Hutt said Troy's criticized actions were neither new nor novel for FDA chief counsels.
As of press time it was unclear whether Hinchey's $500,000 penalty amendment would survive a House-Senate conference on FDA's budget.
Risk-Based Bioresearch Monitoring Change
FDA's bioresearch monitoring (BIMO) program will undergo a paradigm shift beginning later this year. The program inspects clinical trial data that support marketing applications for drugs, biologics, and medical devices. The shift is part of the agency's broadening risk management process, according to FDA clinical science and Good Clinical Practices director David Lepay. Speaking at the Drug Information Association's annual meeting in June, Lepay said he sees the monitoring program evolving so that its actions will not be as predictable as they are now. BIMO inspections today tend to look at data in marketing applications, have inspectors review three clinical sites per application, and focus on the largest clinical sites.
Lepay said that beginning next year, industry will see FDA focusing more on at-risk populations and higher-risk products and protocols. He said he would also like to see more attention given to complaints received at the agency. This would be especially true if there is enough information behind the complaints to allow a thorough evaluation.
FDA's GMP initiative has provided the impetus for a “quality systems approach” across the agency, including the BIMO program, Lepay said. “Out of that will come a broad look for us that hasn't happened since the 1970s when we put in place the BIMO program and our regulations,” he said.
Lepay said BIMO's inspections will need to assess how “less can be more. In fact you can do less of many things, and, if [what's done is] chosen properly and executed properly, your result and performance can be more.” He said the agency needs to get away from a cookie-cutter approach. For example, focusing on a reporting error instead of paying enough attention to the real safety parameters in a study is a drawback of such an approach.
Additionally, Lepay said FDA's new approach will see differences across each center. For example, device sponsors tend to be small, have small monitoring staffs, and lack systems controls, while large pharmaceutical companies have perfected much of what goes into monitoring. He said it might be beneficial to focus on a specific monitoring activity in the device area rather than in the drug area.
In response to an audience member's question on what current BIMO inspections are citing, Lepay said recent violations fall into five basic categories. These are protocol violations, recordkeeping, informed consent, product accountability, and adverse- event reporting.
Sponsor-Monitor Reports Can't Be Shielded from FDA
Sponsor-monitoring reports for clinical trials are not viewed as “internal audits.” Thus, FDA can review them during inspections, the agency said in a recent warning letter to pacemaker manufacturer Biotronik Inc. (Lake Oswego, OR). The letter was issued after Biotronik refused to provide the reports during an FDA inspection.
“Quality audits or ‘internal audits' as required by the quality system regulation (21 CFR Part 820) refer to manufacturing processes and are generally exempt from FDA review,” the letter said. Because Biotronik refused to produce the reports, FDA said it could not determine if the inspected study's monitoring could ensure investigator compliance.
FDA also cited Biotronik for failing to secure a clinical investigator's compliance with the investigational plan and applicable FDA regulations. FDA said, “despite periodic clinical monitoring visits from your firm's designated monitors, violations were repeatedly committed at the sites during the clinical investigation.”
Patient Lifts in Trouble
Two device makers came under public scrutiny in July for failures involving patient lifts. The first case involved 26 Faaborg Patient Lifts (Models PL, VL, and Solution/Nordic Series) FDA seized from their U.S. distributor, Moving Solutions Inc. (Downers Grove, IL). The agency said the devices could break, causing serious harm to patients. The seizure followed a complaint filed in federal court. According to a press release from the Northern Illinois U.S. Attorney's Office, the complaint alleges that the company violated the FD&C Act.
The lifts were described as mechanical slings used to lift and move patients from a bed to a wheelchair. About 850 were distributed to hospitals, nursing homes, and private parties, the release said. FDA received reports about one patient dying and another being seriously injured. A bolt that supports the hanger bar and the patient sling broke from excessive wear, causing patients to be dropped, the reports alleged. The release said Moving Solutions failed to report the patient death to FDA. Earlier this year, FDA reported that the firm was conducting a Class 1 recall of 865 patient lifts because of a faulty design. Class 1 recalls are the agency's most serious category.
The second case involved a Class 1 recall issued by Arjo Inc. (Roselle, IL) for its Alenti Lift Hygiene Chair because of serious injuries from tipping incidents. The chairs are designed to lift and move patients for bathing. FDA's recall notice said “reported causes of the incidents include lift instability on sloped floors, casters falling off of the lift while in use, patients leaning or shifting weight in the seat, and brakes not being applied. Additionally, the device labeling does not properly instruct the healthcare professional on how to properly secure the patient.”
Eye Laser Recalled
FDA says Carl Zeiss Meditec (Dublin, CA) is recalling its eye laser Visulas 532s with Visulink 532/U because of a defect with the laser's mirror. According to the Class 1 recall notice, the reflective mirror coating can tear and loosen from the mirror surface. “The faulty mirror may misdirect the laser beam to an unintended target in or on the eye resulting in retinal bleeding and/or burns due to excessive laser energy in the eye,” it says.
Alternative Premarket Procedures Extended
FDA in July issued a guidance for industry and FDA staff titled A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures. The new document supplements a June 2003 guidance on the topic. The pilot program is being extended for a second year and will remain active until at least June 2005.
According to FDA, the program will assess the feasibility of using an internationally harmonized format and content for premarket approval and 510(k) submissions.
This guidance supplements the Global Harmonization Task Force draft STED document (Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices) in two ways:
•It provides administrative information and guidance to device manufacturers who are considering using the draft STED document to submit a PMA application or 510(k) premarket notification in a harmonized format.
•It describes the extent to which harmonized documentation may need to be supplemented by additional information to ensure compliance with U.S. requirements.
To access the guidance, visit FDA's Web site at www.fda.gov/cdrh/ode/guidance/1347.html.
Guidance on Export Certificates
A newly issued guidance for industry is called FDA Export Certificates. It provides a general description of FDA export certificates that are issued to industry and foreign governments. The certificates assist firms that export products from the United States to countries that require proof of their U.S. regulatory status. The guidance lists the seven types of export certificates issued by FDA and explains the regulations covering their issuance using a question-and-answer format.
Included are reasons why FDA would refuse to issue a certificate, charges made for export certificates, and legal requirements for exporting adulterated or misbranded products. In addition, the guidance lists current good manufacturing practices requirements for drugs, devices, and biologics.
The guidance can be accessed at FDA's Web site, www.fda.gov/cber/gdlns/exprtcert.htm.
Medical Leeches Are Devices
FDA in July cleared a Ricarimpex SAS 510(k) for using medicinal leeches to “help heal skin grafts by removing blood pooled under the graft and restore blood circulation in blocked veins by removing pooled blood.” According to an FDA press release, the French company has been breeding leeches for 150 years. They are currently handled in a certified facility that tracks each lot. FDA based its clearance on published literature detailing the use of leeches in medicine and safety data provided by the firm. “FDA also reviewed information on how the leeches are fed, their environment, and the personnel who handle them,” the release said.
This follows FDA's decision in January to regulate the use of maggots for medical use. The disinfected fly larvae, when applied to a wound and covered with a cagelike dressing, can liquefy dead tissue, kill harmful bacteria, and stimulate healing.
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