Originally Published MDDI March 2005
FDA withdraws a direct final rule in the face of one man's significant adverse comment.
James G. Dickinson
FDA and Medicare to Collaborate | FDA Guidance on Stents | Daniel Troy Joins DC Law Firm | Slasher of Warning Letters Leaves HHS | QSR Violations at BioHorizons | Cyberonics, FDA Disagree on Complaints | Blocked Airway Adapters Recalled
It's not often that a lone individual can cause a huge federal bureaucracy to make a 180-degree reversal. But it happened on January 18, when FDA published in the Federal Register a notice headed “Public Information Regulations; Withdrawal.” In it, FDA recorded, with no further details, that it was withdrawing a direct final rule it had promulgated on September 2, 2004. The rule would have built three Freedom of Information Act (FOIA) exemptions into its public information regulations. FDA said it withdrew the rule because it had “received significant adverse comment.”
One exemption covered records that might compromise homeland security. Another exempted trade secrets and confidential information, such as agency internal personnel rules and practices. The third addressed personal privacy reasons not already covered in the agency's regulations.
When published, the rule provoked only two comments on the exemptions. Perhaps their wording seemed too obscure and inconsequential to most Federal Register readers.
One of the comments came from a B. Sachau, of Florham Park, NJ, who complained simply that the direct final rule was “too broad. It is important that this rule make clear that in no case should records be denied simply to deny the public access. There must be good cause. I think a statement like that should be included.”
The other comment came from veteran medical device and drug industry GMP consultant Paul G. King. His comments turned FDA around.
King used an arresting device on his first page. The rule said it might convert into a notice-and-comment proposed rulemaking if it received strong adverse comments. So he did just that. He placed a bold black box around a bold heading reading “FORMAL SIGNIFICANT ADVERSE COMMENTS.”
In the exposition that followed, King evoked a litany of bad news and public-confidence hits FDA has received in recent months. His comments included the following:
• Since congressional scrutiny “has clearly established that FDA is openly putting protecting the interests of the pharmaceutical industry above the public health...[it] should be clear that the activities of FDA need to be, if anything, opened up to the public.”
• Because of recent “increases in the body of evidence that FDA is knowingly operating outside of its legal statutory authorities and, quite literally, knowingly aiding in the obstruction of the agency's mandate to protect the health of the public that have been uncovered through FOI Act requests under the current rules, it is easy to see why FDA is anxious to change those rules in a manner that reduces transparency and public access…[King would] strongly counsel the agency to resist this ‘hide-the-evidence' impulse if it wishes to preserve the limited level of public trust that the public still has in the agency and its actions.”
King's comments then lectured FDA on the FOIA's purpose and intentions. He charged the agency with wrongdoings that would never have come to light were it not for FOI disclosures under current rules. He recited instances in 1999 and 2000 where FDA knowingly participated in illegal meetings. Although they were supposed to be open to the public, they were effectively closed through failure to provide public notice of them. In addition, King cited FDA meetings that were billed as public but were effectively closed to the public for other reasons. For example, cost-to-attend barriers in the form of registration fees were imposed at conferences where such meetings were held.
King also accused FDA of “knowingly and willfully illegally ignoring” the law requiring biennial inspections. He said FDA failed to prosecute firms that have “a knowing pattern of conduct that continually introduces adulterated and misbranded drugs into commerce.” He also accused the agency of “failing to mandate the removal of all forms of the cumulative poison mercury from vaccines,” among other illegal acts.
King linked FDA's direct final rule to the Bush administration's notorious penchant for secrecy. He said he “finds that FDA and other governmental health agencies currently seem to be moving, under the guise of the Patriot Act and presidential executive orders, [emphasis in original] to make it much more difficult for the public to discover ‘sensitive' information under the FOIA in future.” He then proceeded to itemize explicit objections to the direct final rule's wording and to suggest revisions.
King opined that even if FDA adopted his revisions, public skepticism would increase. King wrote that the public would question “FDA's willingness to protect the public health.” He suggested that FDA may “knowingly sacrifice public health in order to serve the greed-driven interests of the industries...that the agency is supposed to be regulating.”
FDA was convinced. Or so it seems. It has not said whether it will resurrect this project as a formal notice-and-comment proposed rulemaking. However, the agency has become much more unpopular than it was last September, when it launched the direct final rule. Also, Daniel Troy, the chief counsel who promoted the rule, has left the agency. Because of these factors, King's victory might be assumed.
FDA and the Centers for Medicare and Medicaid Services (CMS) have agreed to work together more in four specific areas. The intent is to speed patient access to innovative medical technologies. The increased collaboration was announced on January 14 by outgoing HHS secretary Tommy Thompson. He says it is part of an overall department initiative to move medical innovations forward.
Currently, agencies automatically review products serially. With the new collaboration, the agencies will try to work in parallel upon request of a sponsor, says a department task force report.
According to the task force, greater collaboration between FDA and CMS can “create resource and time efficiencies in moving medical products from the bench to the bedside.” In addition, it says, it can “spur new, innovative medical product development and better inform consumers and healthcare providers.”
In response, FDA and CMS have agreed to the following collaborative activities:
• Parallel review. At the request of an applicant and with the concurrence of both agencies, FDA regulatory review and CMS review would be conducted in parallel to minimize delays between marketing approval and reimbursement.
• Humanitarian device exemptions. FDA and CMS will work together to coordinate marketing approval, postmarket evaluations, and reimbursement approvals for humanitarian device exemptions.
• Summaries of safety and effectiveness. Once a medical product has been approved, FDA may draft a document, such as a Summary of Safety and Effectiveness. The document would describe the evidence reviewed by the agency to reach its decision, its analysis of the evidence, and the basis for its conclusion. After several weeks—to allow time for redaction of trade-secret, confidential commercial, and other information protected by law from public disclosure—FDA would make the summary documents available to the public on its Web site. To reduce the time between a premarket approval decision and a postmarket coverage or payment determination for a new medical product, FDA would expedite redaction of select summaries at CMS's request if the product is eligible for coverage/payment by CMS or its contractors.
• Postmarket surveillance data. Currently, FDA use of CMS data for postmarket surveillance activities is limited. The task force says greater use of existing information and mechanisms and collection of new data through the new Medicare drug benefit could provide FDA, CMS, industry, and, ultimately, the public with invaluable information on use of medical products. FDA and CMS will start several pilot projects this year to collect safety information on approved medical products.
CDRH has issued a guidance for industry and FDA staff called Non- Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems. The guidance will help in preparing and reviewing nonclinical test protocols, methods, data, reports, and labeling for intravascular stents and their delivery systems.
The guidance addresses self- expanding, balloon-expandable extracranial intravascular stents and their delivery systems. CDRH says the scope includes extracranial intravascular stents placed in coronary, central, or peripheral arteries and saphenous vein grafts, but is not limited to stents used in those locations. Other vascular indications outside of the intracranial vasculature also are included. Not covered are nonvascular stents meant for use outside the vasculature. The guidance also does not include stents used in the intracranial vasculature.
According to CDRH, some of the guidance's tests and labeling recommendations are relevant to covered, drug-eluting, and biodegradable stents. They also apply to stents used to treat aneurysms or dissections. However, it says, FDA recommends additional testing to fully characterize such devices. Staff members are available to discuss testing for these stents and indications.
To view the guidance, visit www.fda.gov/cdrh/ode/guidance/1545.html.
Former FDA chief counsel Daniel Troy and his special assistant, Coleen Klasmeier, joined Sidley Austin Brown & Wood in January. Troy and Klasmeier left FDA shortly after the presidential election in November. They are now based in Washington, DC, as part of the firm's life sciences practice. However, Troy will also see duty in the firm's New York office and will serve as a member of the appellate litigation group.
“In addition to providing strategic counseling on FDA-related matters, Mr. Troy will practice administrative and constitutional law and litigation,” a news release said. Troy will focus on the pharmaceutical, biotechnology, food, medical device, cosmetic, and media industries. Klasmeier will focus on policy, regulatory, and litigation matters affecting the pharmaceutical, medical device, and food industries.
HHS Deputy Secretary Claude A. Allen has transferred to the White House as President Bush's domestic policy assistant. Allen, a Bush administration appointee, cut FDA's output of warning letters by 50%.
In November 2001, Allen issued a directive ordering that all warning and similar regulatory letters must be vetted for legal sufficiency in the office of FDA's then–chief counsel, Daniel Troy. The effect was a precipitous decline from 1154 letters in 2000 to 545 in 2003.
McKenna, Long & Aldridge partner Larry Pilot, a former FDA deputy director of medical device compliance, reflected on the policy's effects after Troy announced his resignation. Pilot said the resignation had not “helped the situation at all. There's still a lot of garbage going out. There are fewer warning letters, but as far as I'm concerned, not enough fewer.”
Allen is replacing Margaret Spellings, who was recently nominated for U.S. secretary of education.
QSR Violations at BioHorizons
FDA says a recent inspection of Birmingham, AL–based BioHorizons Implant Systems found significant QSR violations. The agency claims the violations involve the dental devices the firm makes, including endosseous implants.
BioHorizons had not conducted internal audits of its quality system for several years, according to a December 27, 2004, warning letter. The firm also failed to conduct device-complaint follow-up investigations and document corrective and preventive actions in response to complaints. Additionally, the letter says, BioHorizons has not documented that each batch of finished devices meets acceptance criteria before release for distribution.
When should an end-of-service user report be classified for FDA purposes as a “complaint”? This was the focus of a disagreement between Cyberonics Inc. and FDA after a five-day inspection at the company's Houston plant.
A December 22, 2004, warning letter called the company's responses to the inspection's findings on its Vagus nerve stimulator incomplete. It said the company did not address underlying issues well enough. It also said Cyberonics had not clearly explained whether it considers user reports of suspected end of service (EOS) as product complaints.
The letter further said the firm had not been able to determine the causes of many user reports of suspected EOS or high lead impedance. It said that the company had not “determined and documented how many reimplants were due to normal/actual EOS, suspected EOS, or high lead impedance.”
Although Cyberonics had “identified several theoretical causes of high lead impedance complaints (user training, lead manufacturing defects, and design robustness),” the letter continued, it had not completed several proposed corrective actions. “The effectiveness of these proposed corrective actions cannot be determined until you provide the results of your firm's monitoring of the high lead impedance complaints,” FDA said.
FDA's letter also took issue with a company statement implying FDA's premarket approval of the Vagus nerve stimulator also covered approval of the firm's design controls. “This is not true,” FDA's letter said. The design control steps “must be continuously maintained throughout the device design life cycle to ensure compliance with 21 CFR 820.30.”
FDA says Unomedical Inc. has begun a Class 1 recall, the agency's most severe classification. The company will recall two lots of its Hospitak brand 22- and 15-mm airway adapters. The adapters were found to be blocked or occluded, which could prevent exhalation or inhalation.
The adapters are used as an accessory connector for extending airway circuits and attaching various breathing circuit components, such as reservoir bags. The recalled lots are numbered 04-40 and 04-41 and dated 2004 09 and 2004 10, respectively. FDA says health professionals who use Hospitak adapters should check with Unomedical before using the products to make sure they are not occluded.
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