Device Industry Begins Preparation for Excise Tax as Some Call for Repeal
Although the excise tax on medical devices that was part of the health reform bill does not take effect until 2013, members of the device industry have already begun preparing for its imposition, and have indicated that they will continue to call for the repeal or revision of the tax. Some reports are indicating that one of the primary issues associated with the tax will be the determination by the Treasury Department regarding which products and transactions will ultimately be subject to the tax. Industry groups, including the Medical Device Manufacturers Association, have indicated that they will be focusing their efforts in the near future on persuading members of Congress to repeal the tax.

FDA May Further Modify Advisory Panel Voting Processes
FDA officials have indicated that the agency is considering making additional changes to the voting processes of its advisory panels following the announcement earlier this year that panels would no longer use “up-or-down” votes for approval of products. The agency has indicated that it is considering allowing for greater discussion on panel members’ reasoning behind their voting decisions.

Regulatory Notices – FDA Seeks Comments

The FDA has announced that it is seeking comments on the use of rapid response surveys to obtain data on safety information to support quick-turnaround decision-making about potential safety problems or risk management solutions when the agency must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health. Comments are due by October 5, 2010. More information is available here.

The FDA has also announced that it has submitted a proposed collection of information regarding premarket notification for medical devices to OMB for review and clearance. Comments on the collection of information are due September 10, 2010. More information is available here.

FDA to Co-Host Meeting on Pediatric Cardiovascular Device Development
The FDA has announced that it will co-host a public workshop, in conjunction with the National Institutes of Health (NIH), and with support from the American Academy of Pediatrics (AAP), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and Interventions (SCAI), entitled “Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices.” The topic to be discussed is pediatric cardiovascular device development. The workshop will be held on September 30, 2010, from 8 a.m. to 5:30 p.m. in San Francisco, California. More information is available here.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

Amid continuing debate about the timing and shape of the Senate’s food safety bill (the House passed a version in July 2009), comes a new issue that affects companies in the food, drug, device and cosmetic industries.

Several months ago, FDA Deputy Chief Counsel for Litigation Eric Blumberg told industry representatives at the FDLI Annual Conference that the agency is prepared to dust off the three-decade-old “Park Doctrine” to augment FDA’s continuing efforts to ratchet up its enforcement profile. The doctrine stems from the United States Supreme Court’s decision in United States v. Park, 421 U.S. 658 (1975). In principle, it allows the government to pursue misdemeanor charges against a corporate officer for alleged violations of the Federal Food, Drug, and Cosmetic Act, regardless of whether the officer is aware of the existence of a violation, as long as the officer holds a position of responsibility so that that individual could have initiated preventive or corrective action and, for whatever reason, failed to do so.

Park represents a strict liability standard, so no warning letter is required. FDA need only request that the Department of Justice file charges based on FDA’s conclusion that an officer is guilty of misconduct, which is effectively defined as failing to know what FDA believes one should have known. In sum, what an executive does not know can be more than harmful.

The scale of punishment for misdemeanors ranges from one year in prison and/or a maximum fine of $100,000 for each count, ranging to much higher where injury or death are involved. Courts can impose mandatory prison sentences, and if FDA believes a substantial risk of injury or death is involved, judges can increase the length of prison sentences.

At a time when corporate resources are stretched, the entire spectrum of regulatory compliance issues has become every bit as critical for senior management and counsel as the other bet-the-company issues that confront each company on a day-to-day basis.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

FDA Extends Comment Period for Proposed Neurological Device Regulations
The FDA has announced that it is reopening until September 7, 2010, the comment period for the proposed rule and guidance published in the Federal Register of April 5, 2010 (75 FR 17093). The document proposed to amend certain neurological and physical medicine device regulations to establish special controls for these class II devices and to exempt some of these devices from premarket notification requirements. More information is available here and here.

Device Industry Calls for Closer Coordination Between FDA, CMS
Members of the device industry are calling for closer coordination between FDA and CMS related to the competitive bidding process. Stakeholders have said that the two agencies sometimes send mixed messages, due to their different approaches to devices, and particularly for sophisticated therapy products for home use, with CMS focused on pricing and the FDA focused on support services and safety issues, including labeling and training. Members of industry have indicated that they hope that new FDA guidelines on home-use devices will make certain that suppliers ensure that training and support are provided as part of their bids.

FDA Weighs New Approach to Regulation of DTC Genetic Tests
In the wake of a recent GAO report finding that direct-to-consumer genetic tests are providing inaccurate results to the public, the FDA has indicated that it is considering an approach to regulating the tests that would increase oversight without creating heavy reporting burdens on individual companies. The agency’s potential approach, as currently envisioned, would not require the developers of certain diagnostics to submit data on their individual diagnostics, if a manufacturer had previously provided information on the overall indication of the diagnostic to the FDA.

Pharmacies Calling for Removal of Reimportation Amendment from Food Safety Bill
Pharmacies are ramping up their efforts to encourage lawmakers to remove an amendment to the food safety legislation, offered by senator Byron Dorgan, that would allow for the reimportation of drugs from Canada and Mexico into the United States. Pharmacies are stating that the safety of such drugs cannot be ensured and that the use of reimportation means that individuals would not be consulting with a pharmacist at the time that they obtain the drug. Some are speculating that the amendment, which Dorgan also attempted to introduce in the health reform legislation, could prevent the passage of the overall bill, and are thus encouraging its removal.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

Senate Appropriations Committee Funds FDA at Level Requested by President
The Senate Appropriations Committee voted July 15 to approve FDA funding at the President’s requested level, to the dismay of certain stakeholders who had hoped that the agency would be funded at the same level as that recently afforded by the House. The funding includes an additional $2 million for the Office of Generic Drugs and an offset of $5 million, to be determined by the Commissioner. The Committee also expressed its general support for generic drug user fees, for an electronic drug pedigree system that would track drugs as they move through the supply chain, and for guidance from the agency on limiting antibiotics in animal feed.

Mandatory Recall Authority Bill Introduced in Congress
Representative Edolphus Towns has introduced a bill that would give the FDA mandatory recall authority for drugs posing a risk to human health. The bill would permit the agency to order that distribution of a drug stop immediately and be the subject of a recall where the drug posed a risk of serious harm to humans or animals

FDA Withdraws Rule on Pediatric Medical Device Information
The FDA has announced that it has withdrawn a direct final rule that would have required the submission of readily available pediatric medical device information as a part of premarket approval applications, requests for humanitarian use device exemptions, and any product development protocols. The agency decided to withdraw the rule due to significant adverse comment received. More information is available at here.

Mark Mansour is a partner in the firm, Bryan Cave, LLP



House Committee Votes to Increase FDA Funding
A House Appropriations subcommittee has voted to increase the FDA’s budget by $55 million over the President’s request. The panel passed by unanimous consent the first proposed FDA spending bill for the 2011 fiscal year, funding the agency at $2.57 billion.

Administration Releases Plan Requiring Reporting of Counterfeit Products
The Obama administration has released a plan requiring device makers to report counterfeit products and to submit lists of their products to the FDA twice a year so the agency can better track legitimately marketed devices.

FDA Seeks Comments on Recordkeeping Requirements for Medical Devices
The FDA is seeking comments from the public regarding recordkeeping requirements related to the medical devices current good manufacturing practice quality system regulation. Comments are due by August 23, 2010. More information is available here.

FDA Issues Notice of Termination of EUAs for Certain in vitro Diagnostic Devices
The FDA has issued a notice of the termination of the declarations of emergency justifying Emergency Use Authorizations (EUAs) of certain in vitro diagnostic devices, personal respiratory protection devices, and antiviral products that were issued in response to the public health emergency involving 2009 H1N1 Influenza.

Mark Mansour is a partner in the firm, Bryan Cave, LLP