The deadline for interested parties to submit an application for FY 2015 new technology add-on payments under the Medicare inpatient prospective payment system (IPPS) is November 25, 2013.
A recent OIG report links the growing presence of physician-owned distributorships, or PODs, to increased spinal surgery volumes and potentially increased Medicare costs. The OIG notes a “substantial presence” of PODs in the spinal device market, with PODs supplying spinal devices for 19% of the spinal fusion surgeries billed to Medicare in FY 2011. According to the OIG, hospitals that purchased devices from PODs performed more spinal surgeries in 2012 than hospitals that did not purchase from PODs, and hospitals increased the rate of growth in the number of spinal surgeries after they began purchasing from PODs. Hospitals identified surgeon preference as the strongest influence on their decisions to purchase spinal devices from PODs. The OIG also disagrees with PODs’ claims that their devices cost less than those from other suppliers; rather, in the categories examined by the OIG, the devices cost the same as or more than devices from companies not owned by physicians. This fact, coupled with increased volumes, according to the OIG, could increase overall Medicare costs over time. In addition, the OIG raises concerns about inconsistencies in hospital policies regarding physician disclosure of ownership to either hospitals or their patients of interests in PODs (although the OIG suggests that the new “Sunshine Act” disclosure rules may improve the ability of hospitals and patients to identify physicians’ investment in device companies). For a case urging an alternative perspective on PODs, see the report on our sister blog, http://www.lifescienceslegalupdate.com/, about a recent complaint filed in the U.S. District Court for the Central District of California that seeks a declaration that the OIG’s Special Fraud Alert on PODs unfairly and unconstitutionally burdens First Amendment rights of free speech and due process. The complaint defends the lawfulness of the physician-owned model, and characterizes the Fraud Alert as the result of a multi-year lobbying campaign by “Big Corporations” forced to compete with small physician-owned entities. For more details, see our full report.
As reported on Reed Smith's Life Sciences Legal Update blog, the local Beijing office of the Ministry of Health (MOH) of the People's Republic of China recently announced that it has started a three-month review of the use of high-value medical consumables and large-scale medical equipment in Beijing. Noting that prior inspections of hospitals had found continuing problems with the misuse and overuse of medical devices to increase profits, the investigation is intended to strengthen hospitals’ management of the use of medical devices and to regulate the use of high value medical consumables. The Beijing MOH will also develop a database that will track the price and model of devices implanted in each patient, require hospitals to improve their purchasing management systems, and conduct periodic inspections of hospitals’ purchasing and management of medical consumables. For more information about this recent investigation and increased life sciences regulatory enforcement in China, see the full post.
CMS Revises Medicare National Coverage Determination Process, Eases Path to Discontinue Outdated Coverage Policies
CMS has announced updates to the process for making Medicare national coverage determinations (NCDs) to provide clarity and transparency with regard to modifications made to the coverage process since the Medicare Modernization Act. Among other things, the notice addresses: the procedures for requesting an NCD or reconsideration of an existing NCD; public participation in the NCD process; informal contacts prior to requesting an NCD; what constitutes a complete, formal request for an NCD or formal request for reconsideration of an existing NCD; external requests for NCDs; CMS internally-generated review of NCDs; and time frames. CMS had previously addressed these topics in a 2003 Federal Register notice and in subsequent subregulatory guidance documents.
Most notably, the notice outlines a new, expedited administrative process to remove certain NCDs that CMS determines to be no longer needed, thereby enabling local Medicare contractors to determine Medicare coverage. In explaining the impetus for its proposal, CMS notes that “[w]e are aware that clinical science and technology evolve and that items and services that were once considered state-of the-art or cutting edge may be replaced by more beneficial technologies or clinical paradigms.” CMS therefore intends to periodically review the inventory of NCDs that have not been reviewed for more than 10 years to evaluate whether there is a continued need for national policies. CMS believes that local contractor discretion is more appropriate in these cases because “the future utilization for items and services within these policies will be limited.” Under the new, streamlined process, rather than use the formal NCD reconsideration process (which generally takes 9 to 12 months), CMS will periodically publish on its website a list of NCDs proposed for removal along with the agency’s rationale. CMS will solicit public comment for 30 calendar days, and then either: (1) follow the proposal to remove the NCD; (2) retain the policy as an NCD; or (3) formally reconsider the NCD and post a tracking sheet to that effect on the CMS coverage website. The final list will be effective upon posting it to the website.
CMS states that the notice does not alter or amend its regulations that establish rules related to the administrative review of NCDs. CMS also states that it continues to “pursue our efforts to work with various sectors of the scientific and medical community to develop and publish on our website documents that describe our approach when analyzing scientific and clinical evidence to develop an NCD.”
The notice is effective on August 7, 2013.
Data collection under the ACA Physician Payment Sunshine Act begins on August 1, 2013. To assist covered manufacturers of pharmaceuticals or medical devices with reporting obligations, CMS has announced new “OPEN PAYMENTS” mobile applications that could be used to track payments and other financial transfers. While physicians are not required to report any information, CMS notes that they could use this technology to help validate reports submitted by manufacturers about payments the physicians have received. In addition, CMS is compiling answers to frequently-asked-questions on the Sunshine Act. On June 22, 2013, CME released a notice in the Federal Register concerning the collection of information under the Sunshine Act, specifically related to the following subjects: registration; attestation; dispute resolution and corrections; record retention; and submitting an assumptions document. Comments are due to CMS by September 20, 2013. Finally, CMS is hosting an educational call on August 8, 2013 for physicians and teaching hospitals on the Sunshine Act policy, with a focus on third party payments, indirect payments, and the Physician Resource Toolkit.
Draft FDA Guidance Recommends Cybersecurity Risk Assessments and Management Plans for Premarket Medical Device Submissions
The Food and Drug Administration (FDA) has announced the availability of a new draft guidance document entitled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The draft guidance identifies cybersecurity issues that medical device manufacturers should consider in preparing premarket submissions for medical devices – including Premarket Notifications (510(k)), Premarket Approval Applications (PMA), Product Development Protocols (PDP), and Humanitarian Device Exemption (HDE) submissions– in order to provide effective cybersecurity management and to reduce the risk that device functionality is intentionally or unintentionally compromised. The draft guidance highlights the need for effective medical device cybersecurity given "the increasing use of wireless, Internet- and network-connected devices and the frequent electronic exchange of medical device-related health information."
FDA’s draft guidance relates to a recommendation by the Government Accountability Office (GAO) in August 2012 that FDA develop and implement a plan to expand its focus on information security risks, with a particular focus on security risks resulting from intentional threats (e.g., hacking, malware).
Comments on the draft guidance should be submitted in writing, or online at www.regulations.gov, by September 12, 2013.
In a related matter, FDA recently released two Safety Communications (available here and here) concerning cybersecurity for medical devices and hospital networks. The Safety Communications recommend that medical device manufacturers and health care facilities take steps to reduce the risk of failure due to cyberattack, which could be initiated by the introduction of malware into the medical equipment or unauthorized access to configuration settings in medical device and hospital networks. Specifically, the Safety Communications recommend the following:
- Device Manufacturers. Device manufacturers should "remain vigilant" about identifying risk and hazards and take "appropriate steps" to reduce the risk of device failure due to cyberattack. This includes reviewing cybersecurity practices and policies to "assure that appropriate safeguards are in place," such as:
--Taking steps to limit unauthorized device access to trusted users only, particularly for those devices that are life-sustaining or could be directly connected to hospital networks;
-- Protecting individual components from exploitation and developing strategies for active security protection appropriate for the device’s use environment;
-- Using design approaches that maintain a device’s critical functionality, even when security has been compromised ("fail-safe" modes); and
-- Providing methods for retention and recovery after an incident where security has been compromised.
- Hospital Networks/Health Care Facilities. Hospital networks and health care facilities should evaluate their network security and take steps to protect the network. This includes:
-- Restricting unauthorized access to the network and networked medical devices;
-- Making certain appropriate antivirus software and firewalls are up-to-date;
-- Monitoring network activity for unauthorized use;
-- Protecting individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services;
-- Contacting the specific device manufacturer if a cybersecurity problem related to a medical device is suspected; and
-- Developing and evaluating strategies to maintain critical functionality during adverse conditions.
Reed Smith will be issuing additional updates in the near future about these recent cybersecurity developments.
OIG Special Fraud Alert Deems Physician-Owned Distributors (PODs) As "Inherently Suspect" Under Anti-Kickback Statute
On March 26, 2013, the HHS Office of Inspector General (OIG) released a Special Fraud Alert highlighting the risks associated with PODs -- physician-owned entities that sell (or arrange for the sale of) implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers. Building on previous OIG and Congressional scrutiny of PODs, the Special Fraud Alert details specific attributes and practices of PODs that the OIG believes “produce substantial fraud and abuse risk and pose dangers to patient safety.” A Reed Smith analysis of the Alert is available on our Life Sciences Legal Update blog.
This post was written by Jennifer Pike.
In recent weeks, the Food and Drug Administration (FDA) has issued a number of new draft and final guidance documents on a range of issues, including financial disclosure by clinical investigators, medical device recalls, prescription drug labeling, and medical devices for pediatric uses. Highlights include the following:
- Financial Disclosure by Clinical Investigators. This final guidance assists in interpreting and complying with regulations governing financial disclosure by clinical investigators. It provides FDA’s responses to the most frequently-asked questions regarding financial disclosure by clinical investigators.
- Distinguishing Medical Device Recalls from Product Enhancements: Reporting Requirements. This draft guidance clarifies when a potential change to a device is a medical device recall, distinguishes those instances from product enhancements, and identifies the reporting requirements for both recalls and product enhancements.
- Labeling for Human Prescription Drug and Biological Products: Implementing the PLR Content and Format Requirements. This final guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products under the Physician Labeling Rule (PLR). It provides recommendations for applicants developing labeling for new prescription drugs and revising labeling for already approved prescription drugs.
- Providing Information about Pediatric Uses of Medical Devices under Section 515A of the Federal Food, Drug, and Cosmetic Act (FFDCA). This draft guidance describes how to compile and submit the readily-available pediatric use information required under the FFDCA.
The Centers for Medicare & Medicaid Services (CMS) released late today its final rule implementing the physician payment transparency provisions of the Patient Protection and Affordable Care Act (Section 6002), commonly referred to as the "Physician Payments Sunshine Act." Among other things, the Act requires drug, device, biological or medical supply manufacturers to report payments or other transfers of value to physicians and other covered recipients. In addition, the Act requires manufacturers and group purchasing organizations (GPOs) to report certain information regarding ownership or investment interests held by a physician in the manufacturer or GPO.
The official version of the final rule, titled “Transparency Reports and Reporting of Physician Ownership of Investment Interests” (the “Final Rule”), will be published in the Federal Register on February 8, 2013. A proposed rule was previously published in the Federal Register on December 19, 2011, for which CMS received over 300 comments from a wide range of stakeholders.
The Final Rule provides important guidance to manufacturers and GPOs regarding the Physician Payments Sunshine Act, resolves several questions remaining after publication of the Proposed Rule, and raises some new ones. Notably, CMS has announced that manufacturers and GPOs will not be required to collect required information until August 1, 2013. Manufacturers and GPOs will be required to report the data for August through December of 2013 to CMS by March 31, 2014 and CMS will release the data publicly by September 30, 2014.
We are in the process of conducting a full review of the lengthy Final Rule and will release shortly a Client Alert providing a detailed analysis of the Rule. In the meantime, please contact Elizabeth Carder-Thompson (202-414-9213), Katie C. Pawlitz (202-414-9233), Nancy E. Bonifant (202-414-9353) or any other member of the Reed Smith Health Care Group with whom you work, if you would like additional information or if you have any questions.
This post was written by Jennifer Pike.
FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. The rule clarifies which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. For certain types of combination products the application of CGMP requirements is straightforward – the constituent parts of a combination product are each subject only to the CGMP requirements applicable to that type of constituent part if the parts are manufactured and marketed separately. In other words, where parts of a combination product are separately manufactured and marketed, they remain separate for the purposes of applying CGMP regulations. The application of CGMP requirements to “single-entity” and “co-packaged” combination products is more complex. Thus, the final rule also sets forth a transparent and streamlined regulatory framework for manufacturers to use when demonstrating compliance with CGMP requirements for such products. Specifically, manufacturers may demonstrate compliance with CGMPs for “single-entity” and “co-packaged” combination products in one of two ways: (1) by demonstrating compliance with the specifics of all CGMP requirements applicable to each of the constituent parts included in the combination product; or (2) if the combination product contains both a drug and a device, demonstrating compliance with either drug CGMPs or quality system regulations for devices, in addition to other requirements set forth in the final rule. “Single-entity” combination products are products comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single-entity. “Co-packaged” combination products are two or more separate products packaged together in a single package or as a unit and comprised two regulated components. The rule becomes effective on July 22, 2013.
On January 8, 2013, the Obama Administration published its latest semiannual regulatory agenda, outlining planned regulatory initiatives in a number of policy areas. The Federal Register version of the agenda includes only a portion of the regulations in the pipeline, however; the full agenda has been posted on the Office of Management and Budget (OMB) web site. Major Department of Health and Human Services (HHS) regulations are highlighted after the jump.
- An HHS Office of Inspector General (OIG) proposed rule that would add new/modify existing safe harbors under the anti-kickback statute; add new/revise existing regulations governing OIG's authority to impose civil money penalties and assessments; add new/revise existing regulations governing OIG's exclusion authority; and codify new exceptions to the beneficiary inducement prohibition (expected July 2013);
- A final Centers for Medicare & Medicaid Services (CMS) rule implementing Affordable Care Act (ACA) provisions related to Medicaid reimbursement for covered outpatient drugs (expected in August 2013);
- A CMS proposed rule to establish Medicare payment safeguards to prevent providers and suppliers that do not meet Medicare requirements from remaining enrolled in or submitting claims to Medicare (expected May 2013);
- Proposed emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers (expected in July 2013);
- A final CMS rule establishing requirements for disclosure of skilled nursing facilities' ownership (expected May 2013);
- A final rule on long-term care facility agreements with hospice agencies (expected October 2013);
- A proposed rule to establish a prospective payment system for Federally Qualified Health Centers (expected June 2013);
- Annual Medicare payment update rules (various dates);
- Various rules implementing insurance-related provisions of the ACA (various dates);
- A final rule modifying HIPAA privacy, security, enforcement, and breach notification rules (expected but not released in December 2012);
- An advance notice of proposed rulemaking to establish a methodology allowing an individual harmed by an offense punishable under HIPAA to receive a percentage of any civil money penalty or monetary settlement collected (expected March 2013);
- A final rule to enhance human subjects research protections (expected April 2013); and
- A Food and Drug Administration (FDA) final rule establishing a unique device identification system for medical devices (expected May 2013).
There are also some surprises on the Administration’s list of “long-term actions” – including the long-overdue final ACA “Sunshine Act” rule requiring applicable manufacturers of drugs, devices, biologicals, or medical supplies to annually report certain payments to physicians or teaching hospitals (“final action” listed as December 2014). Other long-term actions include a final rule implementing ACA requirements related to reporting and returning of overpayments (February 2015); a variety of rules dealing with the 340B discount drug program (timing listed as “to be determined”); and a final HIPAA privacy rule on accounting for disclosures under the Health Information Technology for Economic and Clinical Health Act (TBD).
The Medical Diagnostic Equipment Accessibility Standards Advisory Committee is holding its next meeting on January 22 and 23, 2013 to discuss its February 9, 2012 proposed rule on medical diagnostic equipment accessibility standards. Among other things, the session will focus on standards for transfer surfaces.
This post was written by Jennifer Pike.
The FDA has announced an opportunity for public comment on the statement of work for an assessment for the process of review of medical device submissions. Under the Medical Device User Fee Act of 2012 (MDUFA III), which gives FDA the authority to collect device user fees from industry for 2013-2017, FDA has committed to reaching certain performance goals. Among others, FDA is committed to participate, with the device industry, in a comprehensive assessment of the process for the review of device applications. The assessment will be conducted in two phases by a private, independent contractor. FDA is providing a comment period on the statement of work before requesting proposals for the assessment. Comments should be submitted in writing or electronically, at www.regulations.gov, by February 4, 2013.
This post was written by Jennifer Pike.
On January 2, 2013, the FDA issued three final guidance documents related to drug and medical device submissions. The first guidance, Acceptance and Filing Reviews for Premarket Approval Applications, is intended to clarify the criteria for accepting and filing a premarket approval application (PMA) to assure the consistency of FDA’s acceptance and filing decisions. The guidance is applicable to original PMAs and PMA panel-track supplements reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The second guidance, eCopy Program for Medical Devices Submissions, explains the new electronic copy (eCopy) Program for medical devices submissions, provides the standards for a valid eCopy, and identifies the submission types that must include an eCopy in accordance with such standards for the submission to be processed and accepted for review by FDA. The final guidance, Refuse to Accept Policy for 510(k)s, explains the procedures and criteria FDA intends to use in determining whether a 510(k) submission is administratively complete. The guidance is applicable to 510(k)s reviewed by CDRH and CBER.Comments regarding the guidances may be submitted at any time.
On April 29 and 30, 2013, the Food and Drug Administration (FDA) is hosting a public workshop on “Accessible Standardized Medical Device Labeling." The purpose of the event is to discuss the need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may use device labeling as efficiently and effectively as possible. This public workshop aims to engage stakeholders in active discussion with FDA and to encourage public comments regarding standard content and format for medical device labeling and the use of a repository containing medical device labeling. FDA also is accepting written or electronic comments related to the public workshop; comments will be accepted until April 12, 2013.
On December 7, 2012, the IRS published final regulations that provide guidance on the 2.3% excise tax imposed on any sale occurring after December 31, 2012, of any “taxable medical device” by the manufacturer, producer or importer of such device (such tax enacted as part of the Affordable Care Act (ACA)). A “taxable medical device” is any device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FFDCA)) that is intended for humans, excluding eyeglasses, contact lenses, hearing aids, and any other medical device of a type that is generally purchased by the general public at retail for individual use. The final regulations set forth the IRS’s interpretation of key elements of the excise tax, including the retail exemption, as discussed after the jump.
The final regulations provide that a device defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act that is intended for humans means a device that is listed as a medical device with the Food and Drug Administration (FDA) under section 510(j) of the FFDCA and 21 CFR part 807, pursuant to FDA requirements (or devices that should have been so listed). This definition generally follows the approach taken in the proposed regulations. Furthermore, the final regulations generally provide that a device is considered to be of a type generally purchased by the general public at retail for individual use if: (i) the device is regularly available for purchase and use by individual consumers who are not medical professionals, and (ii) the device’s design demonstrates that it is not primarily intended for use in a medical institution or office, or by medical professionals. The regulations provide a set of non-exclusive factors for use in evaluating whether a taxable medical device qualifies for the retail exemption, as well as a safe harbor provision identifying certain categories of taxable medical devices determined to fall within the retail exemption. The final safe harbor includes: (1) devices that are identified in the FDA’s IVD Home Use Lab Tests (over-the-counter, or OTC, tests) database; (2) devices described as OTC devices in the relevant FDA classification regulation heading; (3) devices that are described as OTC devices in the FDA’s product code name, device classification name, or the classification name field in the FDA’s device registration and listing database; and (4) certain devices that qualify as durable medical equipment (DME), prosthetics, orthotics and supplies (DMEPOS) for which payment is available on a purchase basis under Medicare Part B payment rules in accordance with the fee schedule published by the Centers for Medicare & Medicaid Services (CMS). Devices that qualify as DMEPOS include: (a) prosthetic and orthotic devices as defined in 42 CFR 414.202, that do not require implantation or insertion by a medical professional; (b) parenteral and enteral nutrients, equipment, and supplies as defined in 42 CFR 411.351 and described in 42 CFR 414.102(b);(c) customized items, as described in 42 CFR 414.224; (d) therapeutic shoes as described in 42 CFR 414.228(c); or (e) supplies necessary for the effective use of DME, as described in section 110.3 of chapter 15 of the Medicare Benefit Policy Manual.
The preamble to the regulations also addresses the application of the excise tax to certain specific circumstances, including dual use devices, humanitarian use devices, veterinary devices, and dental instruments. Existing rules governing manufacturer excise taxes, including exemptions for use by the purchaser for further manufacture, or for resale by the purchaser to a second purchaser for use by the second purchaser for further manufacture, and for export, generally will apply to this excise tax, subject to certain exceptions. The preamble to the regulations discusses how these general rules will be applied to medical devices, including guidance on the meaning of manufacturer, importer and sale price. The IRS also addresses in the preamble a number of other issues raised by public comments, including interaction with the ACA’s branded prescription drug (BPD) fee. The IRS notes that there is no statutory basis for providing an exclusion from the device tax for a combination product with both a device and drug component, even if the combination product is taken into account for purposes of computing the BPD fee. Other specific areas addressed include classification of “convenience kits,” associated devices and components of devices, and medical software. The IRS has posed a frequently-asked questions document and other guidance on its web page.
This post was written by Jennifer Pike.
The Food and Drug Administration (FDA) recently issued two draft guidance documents related to the conduct of clinical trials. The first draft guidance, Draft Guidance for IRBs, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in determining whether the proposed research satisfies the criteria for IRB approval. Specifically, the guidance addresses the IRB’s role in reviewing: (1) the qualifications of investigators; (2) the adequacy of research sites; and (3) the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed. Many of the recommendations in the guidance have appeared in other FDA guidance documents or have been communicated to IRBs who have contacted the agency directly about these issues, but FDA has compiled the information here to ensure that all IRBs are aware of and have access to it. When finalized, this guidance will supersede Question 56 in FDA’s January 1998 guidance Institutional Review Board Frequently Asked Questions – Information Sheet Guidance for Institutional Review Boards and Clinical Investigators.
The second draft guidance, Draft Guidance for Industry: Electronic Source Data in Clinical Investigations, provides guidance to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. This guidance revises and updates the draft guidance Electronic Source Documentation in Clinical Investigations. The draft guidance addresses source data (from clinical investigations) used to fill the predefined fields in an electronic case report form (eCRF), according to protocol , and discusses the following topics related to electronic source data: (1) identifying and specifying authorized source data originators; (2) creating data element identifiers to facilitate sponsors, FDA, and other authorized parties in examining the audit trail of data; (3) capturing source data into the eCRF using either manual or electronic capture methods; and (4) investigator responsibilities with respect to reviewing and retaining electronic data. Comments on both guidance documents will be accepted at www.regulations.gov until January 22, 2013.
This post was written by Jennifer Pike.
On December 13, 2012, the FDA issued two draft guidance documents related to product safety and risk minimization. The first guidance, Design Considerations for Devices Intended for Home Use, is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. The guidance identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for reducing or minimizing these unique risks. Factors to consider in designing and developing medical devices for home use include the physical environment, the user, the device or system, the labeling, and the utilization of human factors. The guidance applies to both prescription and over-the-counter medical devices that are intended for home use. The second guidance, Safety Considerations for Product Design to Minimize Medication Errors, provides sponsors of IND applications, new drug applications, biologics licensing applications, abbreviated new drug applications, and nonprescription drugs marketed without an approved application with a set of principles for developing drug products using a systems approach to minimize medication errors relating to product design. The recommendations in the guidance are intended to improve the drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products. This draft guidance is the first in a series of three planned guidance documents to minimize risks contributing to medication errors. Comments on both guidance documents should be submitted to www.regulations.gov by March 13, 2013.
This post was written by Jennifer Pike.
On November 19, 2012, the Food and Drug Administration (FDA) published a notice and an amendment to a proposed rule related to FDA’s implementation of the FDASIA, which was signed into law on July 9, 2012. In the notice, FDA announced that it is seeking information from all stakeholders (including patients, physicians, dentists, and manufacturers) on appropriate uses of the custom device exemption identified in section 520(b) of the FDCA. By way of background, FDASIA amended section 520(b) of the FDCA, to (among other things) establish criteria for a device to qualify for a custom device exemption. Under section 520(b) of the FDCA as amended, “custom devices” are exempted from performance standard or premarket approval requirements if (among other things): (1) the device is “created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing)”; (2) the device is not “generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution”; (3) the device’s purpose is to treat a “unique pathology or physiological condition that no other device is domestically available to treat”; and (4) the device is manufactured for the “special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of the physician or dentist (or other specially qualified person so designated)” or by an individual patient named in such order. Manufacturers are limited to using the custom device only for the purpose of treating a “sufficiently rare condition, such that conducting clinical investigations on such device would be impracticable.” Additionally, production of the device must be limited to no more than five units per year of a particular device type. Lastly, under section 617 of FDASIA, manufacturers will be required to submit an annual report explaining their use of the custom device exemption. Additional details are available after the break.
FDA stated in the notice that it is specifically interested in receiving the following: (1) input on where use of the custom device exemption is appropriate; (2) specific instances where manufacturers, dentists, or physicians would have liked to use, or plan to use the custom device exemption for treatment of a sufficiently rare condition; (3) product areas other than orthopedic and dental devices where the custom device exemption may be useful; (4) the type of information manufacturers intend to require a physician, dentist, or other qualified person to submit to them when ordering a custom device; and (5) how often a custom device is ordered due to unusual anatomical features of the individual physician/dentist, or due to a unique need in the physician’s/dentist’s practice not shared by health professionals of the same specialty (i.e., a special need of a physician or dentist). Comments must be submitted by January 18, 2013.
FDASIA also required FDA to create a unique device identification (UDI) system by amending section 519(f) of the FDCA. Pursuant to this mandate, FDA published a proposed rule on July 10, 2012 setting forth proposed unique device identifier labeling requirements, proposed requirements relating to issuing Agencies and submission of data to the Global Unique Device Identification Database (GUDID), and proposed conforming amendments to several existing FDA regulations. The proposed rule included a phased implementation of the rule’s requirements. In the amendment to the proposed rule published on November 19, 2012, FDA adjusted the proposed effective dates for certain categories of devices. Specifically, under the proposed rule as amended, the requirements applicable to implantable, life-supporting, and life-sustaining devices would be effective no later than 2 years from finalization of the rule. Therefore, implantable, life-supporting, and life-sustaining devices that are not already subject to a 1-year effective date would be required to bear a UDI within 2 years following the publication of a final rule. Because labelers of devices labeled with a UDI must submit information concerning the device to the GUDID, all labelers of all implantable, life-supporting, and life-sustaining devices would be required to submit data to the GUDID within 2 years of the date FDA publishes a final rule. FDA noted that the amendment to the proposed rule has not extended the proposed rule’s comment period, which closed on November 7, 2012.
On November 21, 2012, the Massachusetts Public Health Council finalized amendments to the State’s Marketing Code of Conduct, which restricts certain payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners and imposes other disclosure requirements regarding such payments. The rules, which are effective December 7, 2012, are summarized on the Reed Smith’s Life Sciences Legal Update blog.