Industry and FDA Reach Tentative Agreement on User Fees Representatives of the medical device ind

Industry and FDA Reach Tentative Agreement on User Fees

Representatives of the medical device industry and the U.S. Food and Drug Administration (FDA) have agreed on the next level of funding for the agency’s user fee program, which was set to expire in September.

The industry has agreed to double the fees paid to the FDA provided a more predictable and quicker review process for new device applications is provided in return. The FDA agreed to hire an outside consultant to analyze its review system. The FDA also agreed to meet with device manufacturers halfway through the review process to provide more time to respond to questions.

Industry execs have argued that one of the biggest obstacles to securing funding for new technology—the lifeblood of product development in the device sector—has been slower review times and an increasingly onerous and unpredictable review process.

The industry will pay about $595 million during the next five years, which is an increase from $287 million in the last iteration of the Medical Device User Fee Act. The increased fees are intended to give the FDA the ability to hire additional reviewers, lower the ratio of managers to reviewers and enhance training for reviewers. Fee agreements, which provide only a portion of the FDA’s funding (the rest is appropriated in the yearly federal budget) must be renewed every five years and then authorized by Congress.

According to meeting minutes posted on the agency’s website, personnel from the FDA and its Center for Devices and Radiological Health have met with members of the device industry nearly 30 times in the past year to negotiate fees, review times and other aspects of the program.

At one point, regulators had proposed as much as $805 million in user fees, according to minutes of a Nov. 29 meeting posted on the agency’s website. Industry groups such as the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association countered with a $447 million offer,according to transcripts of a Dec. 6 meeting. Minutes from any subsequent meetings have yet to be posted. The device industry estimated its $447 million offer would account for 26 percent of the agency’s medical device review budget by fiscal 2017, the final year of the next user fee cycle.

“The tentative new user fee agreement puts in place a framework that will benefit FDA and industry, but most importantly patients by accelerating the development and approval of safe and effective treatments and diagnostics,” said Stephen J. Ubl, AdvaMed’s president and CEO. “The

improvements in the agreement provide FDA and medical technology companies the tools needed to improve the efficiency and consistency of the review process.”

According to a press release fromAdvaMed the fees agreed to by FDA and the trade associations call for the agency to:

• Achieve reductions in total review times, measuring from the time of submission to the time FDA makes a decision on a premarket application (PMA) or a 510(k) submission. The total time is the most meaningful measure of the product approval process;

• Achieve significant performance improvements for premarket approval (PMA) and 510(k) applications relative to a product’s current performance;

• Leave “no submission behind” by requiring the agency to meet with companies if a performance goal on a PMA or 510(k) is missed and work out a plan for completing work on the submission;

• Provide a substantive interaction with applicants halfway through the targeted time for completion of review, thus ensuring that a company can have time to properly respond to appropriate questions; and

• Implement an analysis of FDA’smanagement of the review process by an independent consulting organization, coupled with an FDA corrective action plan toaddress opportunities for improvement.

“AdvaMed looks forward to a productive working relationship with FDA under the agreement. The user fee agreement is not self-executing. It requires consistent and efficient administration by FDA leadership,” Ubl said. “It is in the interests ofpatients and the American economy that this agreement functions well, and we will work with FDA to help make that happen.”

Ubl thanked FDA Commissioner Margaret Hamburg, CDRH Director Jeffrey Shuren M.D. and other senior FDA leaders for their work on the agreement, and he praised the cooperation among the trade associations involved in the negotiations.

Ubl said his group would work with members of Congress from both parties, FDA and other stakeholders to ensure the agreement wins approval before the Sept. 30 deadline. A hearing in the House is scheduled for Feb. 15.

Warning Letter Spurs DePuy to Halt Custom Device Sales

The arrows continue to fly in the direction of Johnson & Johnson’s DePuy Orthopaedics division. And, yet again, the U.S. Food and Drug Administration (FDA) is holding the bow. The FDA issued a warning letter to DePuy for allegedly marketing products that had not properly been cleared by the agency.

The FDA’s Center for Devices andRadiological Health (CDRH) sent a warning letter dated Dec. 8, outlining devices or device components it claims lack proper premarket approval (PMA) clearance or which were modified in such a way that they require a new 510(k) application.

The agency said DePuy also failed to notify regulators that it planned to distribute 14 products as custom devices. The company marketed them as custom because they were designed to conform with different patients’ anatomies. The agency disagreed.

“These devices do not deviate from generally available devices or from applicable performance standards, and they have common, standardized design characteristics, chemical and material compositions, or manufacturing processes,” wrote Steven D. Silverman, director of the Office of Compliance at CDRH. “Although the devices’ size and shape may vary with each patient’s anatomy, the standardized design characteristics do not vary among the devices manufactured. The fact that final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices.”

The agency urged the Warsaw, Ind.-based device maker to “take prompt action” to address the issues, or face possible fines, seizure and injunction.

The letter was based on information gathered during FDA inspections that took place from May 10 to June 7 last year and also noted several quality issues,including inadequate complaint review procedures and inadequate procedures to ensure devices conform to a user’s needs, according to the letter.

Among the products cited in the warning letter were the PFC Sigma Knee System, the Agility Total Ankle Prosthesis, Global humeral stems and TriFlange Acetabular Cups as well as additional total hip components.

The company is halting sales of all custom devices—not just the products cited in the FDA letter—for the foreseeable future.

“While DePuy believes it had complied with FDA requirements, the company has made the decision at this time not to provide custom devices,” according to a statement released on Jan. 18.

The FDA also claimed DePuy had failed to establish adequate design procedures to ensure the devices conformed to their intended use. In addition, the agency said the company lacked a proper statistical method for detecting recurring quality problems.

“DePuy has implemented a number of actions to address concerns raised in the inspection, and has responded to all concerns raised in the warning letter,” the company statement continued.

Custom devices and instruments have caused FDA regulators to scratch their heads recently.
ConforMIS was the first company to receive 510(k) clearance to market its iTotal CR Knee Replacement System in early 2011, following a lengthy review period. In 2010, Biomet received an FDA warning letter regarding itsSignature customized cutting guides for total knee replacement, and the companytemporarily suspended marketing of thedevice until it was cleared by the agency in February of 2011. Stryker received 510(k) clearance in May last year for the Shapematch, which it acquired when itpurchased OtisMed.

In other Johnson & Johnson news, more company executives have been deposed in the ongoing DePuy Orthopedics ASR metal-on-metal hip implant lawsuit.

Among the depositions are DePuy’s senior engineering fellow, the director of Strategic Outcomes, the vice president of Worldwide Regulatory Affairs, and the vice president of Worldwide Clinical Affairs. The depositions are scheduled to take place in February and March 2012. A deposition is the out-of-court oral testimony of a witness that is reduced to writing for later use in court or for discovery purposes. It is commonly used and almost always is conducted outside of court by the lawyers themselves (that is, the judge is not present to supervise the examination).

Sally Hunter, worldwide vice president of clinical affairs and one of the executives recently deposed, was quoted in The New York Times last March, citing declining sales as the reason the company began phasing out its ASR hip replacement implants. The company launched a voluntary recall of the ASR devices five months later, acknowledging unusually high rates of revision surgery needed within five years of implant, rates that weren’t previously seen in post-market evaluations. By then about 83,000 people already had received the device.