FDA Proposes Criteria for Determining Completeness of 510(k) Submissions

The U.S. Food and Drug Administration (FDA) has released a draft guidance titled “Refuse to Accept Policy for 510(k)s.” In the document, the agency proposes it only will accept a premarket notification—commonly known as a 510(k)—submission for substantive review if it is deemed to be “complete.” The document also outlines the procedures and criteria it will use to determine completeness of an application for 510(k) clearance. This guidance is applicable to 510(k)s reviewed in the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research.

For a device to be eligible for 510(k) clearance as opposed to an FDA approval, the device must be found to be substantially equivalent to an existing device. It must have the same intended use as the predicate device, and must have either the same technological characteristics as the predicate device, or have different technological characteristics accompanied by a submission containing information, including appropriate clinical or scientific data if necessary, that demonstrates the device is as safe and effective as the predicate and does not raise different questions of safety and effectiveness.

The previous guidances relating to 510(k) refuse-to-accept policy and the checklist currently used for acceptance review have focused on defining broad issues or principles. Additionally, the previous checklist deals largely with administrative elements but it does not address specific content that is essential for 510(k) review. As a result, FDA accepts many inadequate submissions for review and FDA staff invests significant time in constructing extensive letters requesting all of the additional information needed to conduct a substantive review. This approach is an inefficient use of resources and frequently lengthens review times.

According to the proposal, focusing the agency’s resources on complete applications “will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible.”

When the most recent version of the Medical Device User Fee & Modernization Act was approved earlier this year, the FDA promised to speed up review processes in exchange for the hiked user fees companies would be paying. This proposal is one step in the direction of keeping that promise, as focusing on complete applications only will reduce time wasted on back-and-forth with companies regarding inadequate information.

“FDA agreed to performance goals based on the timeliness of reviews,” the proposal reads.
“Acceptance review therefore takes on additional importance in both encouraging quality submissions from sponsors of 510(k) notifications and allowing FDA to appropriately concentrate resources on complete submissions.”

Any comments or suggestions regarding the document must be submitted to the FDA before Sept. 27 to be considered for the final draft.

FDA Document Leak Reveals Agency “Spies” on Employees
The Wall Street Journal reported in mid-July that there was an “accidental disclosure of confidential government files,” including material from the National Health Institute (NIH) and the U.S. Food and Drug Administration (FDA). The leak came from documents-handler Quality Associates, which had been hired by the FDA to handle documents related to a litigation. Quality Associates’ relationship to the NIH is not immediately clear.

An array of documents, emails and correspondences were found available online showing that the FDA was monitoring employees it found to be dissident. The documents allegedly showed that the FDA would retaliate against employees who reported or expressed concerns to the U.S. Congress about drugs or medical devices approved by the agency.

One of the former FDA employees affected by this controversy is Robert C. Smith, M.D., a radiologist and lawyer who used to work for the agency but was placed on administrative leave in 2010. Expressing to management that the FDA was not, in his opinion, “following the law, not following the science, [and] not following FDA core values,” he was placed on leave in July 2010—three months after the surveillance of employee emails began.

In April, the FDA began monitoring the computers of five of its scientists, including Smith, to determine if they were responsible for leaking confidential documents submitted to the agency by medical device firms. The monitoring also uncovered emails between the scientists and congressional staffers and the U.S. Office of Special Counsel, which represents whistle-blowers at federal departments.

Sen. Chuck Grassley (R-Iowa) began an investigation into allegations of the FDA spying on its employees in January this year, in response to the whistleblower allegations. In early June, Grassley indicated he had been promised a response from the FDA repeatedly with no follow through.

“After four months of pushing on our end, at last, the FDA commissioner herself indicated that an FDA response was on the way,” he said. “Then the FDA abruptly switched gears and said an unnamed official in the administration is reviewing the response. That leaves the response in limbo. The FDA staff wouldn’t give any more details. This puts us back to square one, and it’s not a good development from an administration that was supposed to be the most transparent in history.”

Finally, on July 13, the senator received a letter response from FDA Assistant Commissioner for Legislation Jeanne Ireland. The letter noted that the FDA “shared his concern” for the privacy of employees and the preservation of their right to raise concerns with internal procedures and approved technologies. Ireland also states, “At the same time, FDA has important obligations to ensure the integrity of the medical device premarket review process, which requires FDA, including the Center for Devices and Radiological Health, to routinely receive and review trade secrets and confidential commercial information submitted by regulated entities, the disclosure of which could cause competitive harm to the company submitting the information.”

According to Grassley, the private FDA documents refer to whistleblowers as “collaborators,” congressional staff as “ancillary actors,” and newspaper reporters as “media outlet actors.” The documents, Grassley claims, “explicitly authorized, in writing” the agency spying on employees.

Grassley sent a letter to FDA Commissioner Margaret A. Hamburg on July 16 expressing his disapproval of the way the agency has responded to the leak. Grassley also has a letter out to Quality Associates, asking the company how the documents were leaked and for which other agencies the company manages documents.

In his letter to Hamburg, Grassley said it was “simply not credible” that the agency “cannot identify who authorized the spying.” An FDA spokeswoman confirmed that the agency was looking into that question.

Smith now has a private radiology practice in Great Neck, N.Y. He told The New York Times in an interview, “I’m not the kind of guy who ever in his life turns a blind eye to things,” standing by his claims that the FDA is a corrupt organization.

The FDA now is under investigation by Kathleen Sibelius, secretary of the U.S. Department of Health and Human Services.

Massachusetts Makes Significant Changes to Gift Ban Law
The commonwealth of Massachusetts has been battling with industry over the Pharmaceutical and Medical Device Manufacturer Conduct Law that bans gifts from drug and device makers to physicians, as these ostensibly could be viewed as bribes. As part of its annual budget process, the Massachusetts legislature has whittled down provisions in the existing law, also known as the “physician gift ban.”

One of the more significant amendments allows for restaurant meals to be provided to physicians. The revision reads: “The provision of or payment for modest meals and refreshments in connection with non-CME educational presentations for the purpose of educating and informing healthcare practitioners about the benefits, risks and appropriate uses of prescription drugs or medical devices, disease states or other scientific information, provided that such presentations occur in a venue and matter conducive to information communication.”

The change is qualified by two conditions: First, the “gift” of a meal and drinks must be “modest,” and the Department of Public Health can determine what “modest” means in any given context. Second, companies providing such meals to physicians are required to report them to state regulators on a quarterly basis. Companies already are required to disclose other types of industry/provider interactions, so this will not be a significant added burden.

Another important change is that companies now are permitted to provide training to physicians for a certain technology without having a signed sales agreement in hand. Previously, this was not allowed because “training” could trend toward excessive trips to exotic locales with a physician’s family along for the ride. These trips could be seen as a way to elicit a sales agreement rather than real training.
Tom Sommer, president of the Massachusetts Medical Device Industry Council (MassMEDIC), praised the enactment of corrections to the law.

“MassMEDIC is pleased that the state legislature, particularly Senate President Therese Murray and House Speaker Robert DeLeo, and Governor [Deval] Patrick have addressed some of the most onerous portions of the state’s ‘gift ban’ law. Medtech companies now can train doctors, nurses and technicians on new and innovative medical devices before a sales agreement is in place. This will enable healthcare providers to make informed purchasing decisions that have a positive impact on their patients.”

The House also voted to repeal a disclosure rule that requires all financial arrangements between drug and device makers with prescribers to be posted on a website maintained by the state Department of Public Health.

The federal “Sunshine Act” (42 U.S.C. 1320a-7h), so called because of its function in “shining light” on potentially clandestine activities, pre-empts any state law requiring manufacturers to report to a state any marketing expense information that also must be reported to the U.S. Department of Health and Human Services.

Not everyone is pleased with the decision, however. Doctors and medical students alike have had their factions speaking out against relaxing the ban, claiming that gifts, meals, and training trips could lead to newer, more expensive devices and drugs that may not necessarily be better.

A petition of protest signed by 100 medical students and doctors was delivered to Governor Patrick on June 18—10 days before the vote took place.

A letter from Harvard University medical student David Tian and Brown University medical student Reshma Ramachandran included with the petition read, “The trust at the heart of the doctor-patient relationship is being eroded by the perception that doctors are ‘on the take’ from industry.”

This was the third time state lawmakers have attempted to vote down the gift ban. The ban was not lifted, but there were certainly enough amendments added to ameliorate some of the more harsh aspects of the law.

At the federal level, industry executives repeatedly have urged the Centers for Medicare & Medicaid Services to publish its final rule implementing the Physician Payments Sunshine Act, a provision of the Patient Protection and Affordable Care Act that would require pharmaceutical, medical device, biological and medical supply manufacturers to report payments made to providers and teaching hospitals to the Department of Health and Human Services. There still was no final rule as of early September.