Originally Published MDDI November 2004
Originally Published MDDI November 2004
FDA May Not Meet Its User Fee Goals
Not enough data are available to measure FDA's performance in meeting the goals set by MDUFMA.
James G. Dickinson
Inherent in the introduction of user fees for FDA medical device reviews was the idea of quid pro quo. In exchange for a manufacturer's money, FDA would provide a service of equal value. In this case, the service would be an efficient review according to an exhaustive matrix of statutory performance goals. One goal, for example, is that FDA take first actions on 75% of PMA submissions in 2005 within 150 days.
Of course, the money crosses the counter first, and FDA's performance follows later. Now, two years after the law was passed, a General Accounting Office (GAO) report says FDA lacks the data necessary to measure its performance under the act.
In fact, the report says it's doubtful the agency can meet all its user fee goals for medical devices before 2006.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) requires GAO to report on FDA's performance. The office had to measure the agency's performance against FY 2003 and 2004 performance goals, and then determine whether FDA is likely to meet the FY 2005 goals.
GAO also had to report on the amounts FDA obligated in FY 2002 for compliance activities and inspections of device establishments after a device was marketed. This excludes amounts for inspections related to review of medical device applications.
For FY 2003, GAO's report says, FDA's two performance goals could be applied to 53 applications. However, as of last March 31, only one application that was reviewed and received a decision met the requirements to be considered data to assess the performance goals. On that application, FDA reviewed the manufacturer's complete response to the agency's approvable letter. It also approved the application within the goal's established time frame. For FY 2004, there was no application subject to the review tied to performance goals.
GAO said FDA had performance data for some but not all of the performance goals for FY 2005. GAO was able to give preliminary results of FDA's performance against MDUFMA goals. But performance is based on the percentages of actions the agency takes on applications within required review times. The results could change as FDA completes actions on all applications to which performance goals apply.
GAO also reported that FDA obligated more than $128 million for postmarket medical device compliance activities and inspections in FY 2002. The agency also obligated about $109 million for compliance activities for outreach coordination and research. It obligated about $19 million for inspections of manufacturers' device establishments. The inspections included routine surveillance inspections to determine compliance with regulations and inspections resulting from device problem reporting or product recalls.
In its response to the GAO audit, FDA said it generally agreed with the findings. The agency believes it has made “a good beginning in our implementation of MDUFMA,” according to acting commissioner Lester Crawford. “The performance goals that are the primary focus of [GAO's] report are a key feature of MDUFMA, but only one of the challenges we are working to meet. We are also working to meet expectations for third-party establishment inspections, the new regulatory requirements for reprocessed single-use devices, and new provisions for pediatric devices. While we work to make these and other improvements, we're also working to ensure that we maintain our performance in areas that don't have specific MDUFMA performance goals.”
Crawford said FDA's progress has been consistent with the extensive performance improvements the agency is expected to achieve each year through FY 2007.
To view the GAO report, visit the office's Web site at www.gao.gov/new.items/d041022.pdf.
Utah Device Maker Defies FDA in Court
An FDA complaint for permanent injunction filed in August against Utah Medical Products (Midvale, UT) alleged GMP and QSR violations. Utah Medical claims that the complaint contains “allegations . . . [that] constitute conclusions of law that do not require a response.” If they are construed as factual, “they are denied,” the company told the Utah federal court in response.
FDA's complaint seeks an injunction restraining the company from manufacturing, packing, storing, and introducing certain devices into interstate commerce. Those products, according to FDA, have been adulterated by the company's failure to comply with the quality system regulation requirements to the agency's satisfaction.
Washington device lawyers Daniel G. Jarcho and Larry R. Pilot (McKenna Long & Aldridge) filed the company's answer. It says the court should dismiss FDA's case as “barred by the doctrine of laches.” In other words, FDA has wasted too much time in reaching remedies legally available to it.
Additionally, it says, the court should dismiss on the basis of estoppel, because bringing the injunction would be unfair based on the agency's earlier “acts, conduct, and statements.” The case was assigned to Judge Bruce S. Jenkins, a 1978 Carter appointee.
Utah Medical Inc.'s answer says FDA's complaint “represents the latest punitive action” taken by FDA against the company. It says the suit's punitive nature “is evident in a press release and comments to the news media that the FDA issued the date the complaint was filed, three days before the complaint was even served on the defendants.” These statements have damaged the company's business without just cause, the answer maintains.
FDA's press release is posted on the agency's Web site at www.fda.gov/bbs/topics/news/2004/NEW01102.html. In it, acting commissioner Lester M. Crawford is quoted as saying “FDA will not tolerate manufacturing practices that can potentially put patients at risk. Patients have a right to expect that the medical devices used to treat them are safe and effective.”
The release also says FDA filed the complaint after conducting a series of inspections over three years. The inspections revealed a pattern of “significant deviations from the quality system regulation at Utah Medical's Midvale facility. During the most recent inspection, conducted between February 3 and March 3, 2004, FDA investigators found a variety of problems, including the failure to establish that manufacturing processes were adequately controlled, and the failure to have an effective system to identify and correct manufacturing problems.
“Despite repeated warnings from the FDA,” the agency's press release continued, “including a warning letter following one of the inspections, Utah Medical has consistently failed to ensure that its products are manufactured in accordance with the quality system regulation.”
In its court response to FDA's suit, Utah Medical said “No knowledgeable official within the FDA has ever suggested that the [QSR] issues in this case have anything to do with any public health risk associated with the company's medical devices . . . FDA has no evidence to suggest that those QSR issues decrease the level of assurance that the company's products are safe and effective. Nonetheless, the agency's chosen wording for the press release and media comments has led many in the clinical user community to believe otherwise.”
Utah Medical's answer calls FDA's complaint “the most recent incident in a three-year ordeal that the FDA has imposed on the company.”
Utah Medical described four comprehensive FDA inspections that raised issues “without adequate substantiation.” It also mentioned the agency's repeated refusal to engage in dialogue or mediation. The company contests the complaint's demand that its compliance with the QSR requirements be “in a manner that has been found acceptable to FDA.” It says there “is no legal requirement that individuals within the FDA must be satisfied with the specific manner of Utah Medical's regulatory compliance; compliance is determined by the court, by comparing the requirements of the QSR to the procedures in place, and the implementation of those procedures, at the company.”
How Can FDA Stimulate Innovation?
It is critical that sponsors in product development have the best possible handle on data and other requirements necessary for an adequate demonstration of effectiveness. This is according to comments submitted to FDA in August by the Biotechnology Industry Organization (BIO; Washington, DC) on the subject of stimulating technological innovation.
BIO urged early and productive communication between product sponsors and FDA about what will be necessary for demonstration of a new product's effectiveness. It praised FDA's decision to replace “approvable” and “not approvable” letters with “complete response” letters. The organization also stressed the need for FDA to articulate problems and concerns early in the review process.
The comments also called for more-appropriate use of postmarket commitments, stating that FDA has often told sponsors that they need to conduct postmarketing studies at the end of the review process, when sponsors are in an economically fragile position. Thus, the sponsors feel they cannot protest the request because doing so would delay approval.
“If the agency believes postmarket studies will be needed, [then it should] communicate this to the sponsor earlier, rather than later, in the review process,” BIO said in the comments. “This will provide an opportunity for the sponsor to have input not only into whether the studies are, in fact, necessary, but also into the decision about the nature and number of any such studies.” BIO also called for clearer criteria for when and why postmarket studies would be required.
To spur rather than discourage innovation, BIO said FDA should ensure that all new regulatory requirements truly address a clear and identifiable need. They should also be subject to a cost-benefit analysis.
FDA to Coordinate Advertising Policies
Future changes to FDA policies and procedures overseeing advertising and promotion of regulated products will be guided by a “steering committee.” The agency told a Food and Drug Law Institute conference about the soon-to-be-formed in-house committee in September.
Thomas Abrams, director of the Division of Drug Marketing, Advertising, and Communications, reported that the purpose of the committee is to advise “senior FDA leadership” on all issues related to regulation of advertising and promotion, including the need for new policies and procedures. “The committee will coordinate actions taken by the agency with respect to advertising and promotion across all FDA centers, and will coordinate efforts to better inform consumers about the use of drugs and other healthcare products,” Abrams said.
He emphasized that the steering committee is still in the “planning stage.” Details such as who will sit on the committee, when meetings will take place, and the precise functions of the committee have not yet been determined.
Earlier, FDA acting commissioner Lester M. Crawford told a National Press Club luncheon that the committee is “a top priority for the agency.” This is because of the “important role that high-quality information plays in ensuring that medical products are used safely and effectively,” he said. “This new group will help to rationalize FDA policy and procedures, coordinate enforcement efforts, and establish a unitary means of communicating with the public concerning medical product promotion–related policy issues.
“We recognize,” Crawford said, “that there are a number of issues in promotion that have been of concern—for example, the status of outdoor advertising, comparative claims, and implied claims. In the months ahead, look to FDA to provide clarity through guidance on these and other related areas.”
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