September 22, 2014

Bigger FDA Budget Could Be Good News For Medical Device Industry

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It sounds like the FDA is going to be one of relative winners on Capitol Hill when it comes to budget requests for Fiscal Year 2012. While many government agencies are under pressure to scale back, even the Department of Defense is in saving mode and poor NASA has just about given up on getting us to Mars anytime soon, folks we’ve talked to expect the FDA to get pretty close to its modest increase request.

That’s good news in many ways, perhaps even for those who don’t like the FDA having too active role in their lives (hello Medical Device companies).

The reason: Congress and others have “been asking the FDA to do a heck of a lot of stuff without a heck of a lot of money,” notes industry expert Mark Mansour, a partner at AkinGump and fellow AssurX blogger.

Mansour’s logic, and I’ve heard this now elsewhere, is that a better funded FDA will do a better and more consistent job when it comes to regulating food, drugs and medical devices. Much of the complaints I hear about dealing with the FDA, especially from device companies, is that they never know what to expect from one inspector to the next. Or even that FDA focus can change mid-inspection either because an inspector has left or something else changed at the FDA’s end.

In addition, the FDA is getting pressure from folks on Capitol Hill who believe medical device innovation in particular is moving to more friendly regulatory climates such as Europe. “Medical device investors feel they can get a more predictable approval process over there,” Mansour adds.

FDA is also struggling to replace outgoing senior inspectors and other knowledgeable personnel. It takes years for a new FDA inspector to come up to speed. Think baseball where even a phenom like Washington National Bryce Harper isn’t an instant major leaguer, rather than say football where a top draft pick can be an immediate star in the pro’s, which is what the Washington Redskins are banking on with Robert Griffin.

It may be hard for medical device manufacturers and others to hear, but giving the FDA more budget might be good news for everyone.

More money won’t solve everything, of course. The FDA has some organizational and strategic priority choices to confront and reconsider, in addition to getting new people up to speed, and it also needs to work on bringing its medical device class and subclass system into the 21st century, Mansour adds.

But even in these days of cutting political partisanship, almost everyone echoes Mansour, “All agree the FDA’s function is critical.”

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Mark’s Memo: FDA Updates and News Briefs | 09/24/10

Mark Mansour, Partner, Bryan Cave, LLP

Industry, Consumer Advocates Differ in Views of MDUFMA User Fee Negotiations

While consumer advocates are pushing the FDA to increase user fees as part of its next round of negotiations under the Medical Device User Fee and Modernization Act (MDUFMA), industry has indicated that it does not support an increase in such user fees because the FDA has thus far failed to meet its goals put forward in the last round of negotiations. The Medical Device Manufacturers Association has indicated that it is not pleased with the FDA’s progress in meeting its goals, including increased collaboration, predictability, and timeliness, under the MDUFMA and is calling on the agency to work harder toward meeting those goalsbefore it further increases user fees. The agency has indicated that it intends to release draft recommendations regarding user fee reauthorization in about a year’s time and then hold another public meeting. Final recommendations are due to Congress by January 2012. Agency officials have indicated that the changes that the agency is considering with regards to the 510(k) process will also have implications for user fees.

Members of Congress Introduce Bill for Inspection Parity

Four House Democrats in the House of Representatives have released draft legislation that aims to create parity in foreign and domestic inspections of drug manufacturing sites. The legislation would also provide the FDA with mandatory recall authority over drugs.

FDA Seeks Comments on Parallel Review of Medical Products

The FDA and the Centers for Medicare and Medicaid Services (CMS) have indicated that they are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. This process is intended to reduce the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs). The agencies are seeking public comment on what products would be appropriate for parallel review by the two agencies, what procedures should be developed, how a parallel review process should be implemented, and other issues related to the effective operation of the process. The agencies also intend to create a pilot program for parallel review of medical devices. More information is available here.

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

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Mark’s Memo: FDA Updates and News Briefs | 08/11/10

Mark Mansour, Partner, Bryan Cave, LLP

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

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FDA Plans to Use Park Doctrine to Ratchet Up Enforcement Efforts – Corporate Officers Can be Held Strictly Liable for Violations of the FFDCA

Mark Mansour, Partner, 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

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Mark’s Memo: FDA Updates and News Briefs | 08/02/10

Mark Mansour, Partner, 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

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Mark’s Memo: FDA Updates and News Briefs | 07/26/10

Mark Mansour, Partner, 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

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Mark’s Memo: FDA Updates and News Briefs | 07/06/10



Mark Mansour, Partner, Bryan Cave, LLP

Mark Mansour, Partner, 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

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Mark’s Memo: FDA Updates and News Briefs | 06/16/10

Mark Mansour, Partner, Bryan Cave, LLP

Mark Mansour, Partner, Bryan Cave, LLP

FDA: Genetic Testing Kits are Medical Devices

The FDA has sent letters to five manufacturers of genetic testing kits stating that the agency is considering the kits to be medical devices. As such, the agency has said that they need to receive approval from the agency before they can be marketed. The House Energy and Commerce Committee has announced that it too is looking into the tests.

FDA Requests Notifications of Intention to Participate in Meetings on PDUFA Reauthorization

The FDA has issued a notice requesting that public stakeholders notify the agency of their intent to participate in periodic consultation meetings on reauthorization of the Prescription Drug User Fee Act (PDUFA). After the statutory authority for PDUFA expires in September 2012, the FDA will consult stakeholders to develop recommendations for the next PDUFA program. Notifications of intention to participate must be submitted by June 25, 2010. The first stakeholder meeting will be held on July 1, 2010, from 9 a.m. to 11 a.m. More information is available here.

FDA Corrects Dental Device Final Rule

The FDA has issued a notice that it is correcting an error in its Final Rule on dental devices, published on August 4, 2009. More information is available here.

FDA Seeks Comments on Labeling Requirements, Premarket Approval, Drug Co-Development

The FDA is seeking comments on the standardized format and content requirements for the labeling of over-the-counter (OTC) drug products. Comments are due by August 2, 2010. More information is available here.  The FDA is seeking comments on requirements for premarket approval of medical devices. Comments are due by August 9, 2010. More information is available here. The FDA also seeks comments on methods to co-develop two or more distinct investigational drugs intended to be used in combination to treat a disease or condition. FDA is planning to develop guidance for industry and other affected parties on the co-development of two or more novel drugs intended to be used in combination (but not as not fixed-dose combinations) and is seeking public input to identify the affected parties’ information needs concerning such co-development. Comments are due by September 7, 2010. More information is available here.

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

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Mark’s Memo: FDA Updates and News Briefs | 05/05/10

Mark Mansour, Partner, Bryan Cave, LLP

Mark Mansour, Partner, Bryan Cave, LLP

Court Says Patent Settlements May Violate Antitrust Laws

A federal appeals court in New York indicated that patent settlements reached by drug companies may violate antitrust laws when they include payments to rivals to delay the introduction of generic products. The Justice Department has previously asserted that those types of payments may be illegal and the FTC has called on courts to consider the merits of the patents at issue when determining whether such settlements should be valid. FTC Chairman Jonathan Leibowitz has stated that these settlements cost consumers $3.5 billion per year through higher drug prices.

House Committee: FDA Didn’t Pursue Leads on Heparin Contamination

Members of the House Energy and Commerce Committee have stated that they have concluded an investigation into the FDA’s handling of the contaminated heparin crisis and found that the FDA failed to pursue certain leads which could have uncovered those responsible.

Speakers at Conference Advise Companies Not to Wait for FDA Guidance to Use Social Media

Speakers at a recent FDLI annual conference encouraged companies not to wait until after the FDA issues guidance on the use of the internet and social media to use those mediums. They did recommend that companies use caution when using social media or developing certain websites, including not promoting specific products and monitoring the sites and postings regularly.

FDA Seeks Comments on Proposed Collections of Information

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of information on administrative procedures for the Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization. Comments on the collection of information are due July 6, 2010. More information is available here.

The FDA is also seeking comments on for research entitled “Experimental Study of Patient Information Prototypes.” This study is designed to determine, based on different prototype testing, whether consumers are able to comprehend serious warnings, directions for use, drug indications and uses, contraindications, and side effects in the material that is presented. Comments are due July 6, 2010. More information is available at here.

The FDA has also announced that it has submitted a proposed collection of information regarding requirements for submission of labeling for human prescription drugs and biologics in electronic format to the Office of Management and Budget (OMB) for review and clearance. Comments on the collection of information are due June 3, 2010. More information is available here.

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

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Mark’s Memo: FDA Updates and News Briefs | 04/26/10

Mark Mansour, Partner, Bryan Cave, LLP

Mark Mansour, Partner, Bryan Cave, LLP

Industry Reps: FDA Interacting Less with Industry

In their comments regarding ways in which the FDA can improve its openness to industry, industry representatives commented that they have noticed a trend of the FDA being more reluctant to interact with them. Comments included that the agency should respond more quickly to industry input on important issues, keep industry apprised of plans to issue or revise guidance documents, provide more notice about upcoming meetings, and post messages more clearly on its website. Industry groups also encouraged the agency to make better use of available, industry-sponsored educational programs. In addition, some members of the industry called on the FDA to clarify its criteria on product recalls.

FDA May Implement More Strict Approval for RT Devices

The FDA is indicating that it may implement a more strict approval process for certain radiation therapy (RT) devices as a result of faulty design or misuse. The agency is also set to hold a public meeting to gather input on potential new safeguards and possible changes in premarket device testing.

FDA May Regulate Tanning Beds as Class II or III Devices

At a March 25 hearing to discuss a recent report by the International Agency for Research on Cancer, part of the World Health Organization, the panel urged the agency to make tanning beds Class II or III devices. The report, covering X-rays and other devices that emit radiation, reclassified tanning beds into the highest cancer risk category — carcinogenic to humans. The panel also recommended that the FDA require more prominent warning labels for tanning beds.

FDA Compliance Officer: Negotiate Quality Agreements with Wholesalers

At a recent conference, an FDA compliance officer encouraged manufacturers to negotiate quality agreements with wholesalers to ensure safe storage of their products and noted that manufacturers who neglect to do so may risk recalls.

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

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