FDA tells manufacturers what it means to be an accessory

The FDA encourages manufacturers of medical device accessories to use the de novo classification process under Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (FDC Act). In a new guidance document, the FDA explains the definition of accessory for FDC Act purposes, the regulation of such devices, and the process by which manufacturers can obtain a risk-based classification of a new accessory type.

Background

Under Section 201(h) of the FDC Act, the definition of the term “device” includes “accessories.” Thus, all accessories to articles meeting the definition of device, are, themselves, devices. The classification of device accessories has historically taken on one of two methods: (1) shared classification with a “parent” device or (2) by issuance of a unique classification for the accessory. In the second circumstance, an accessory obtains a unique classification because the FDA determines that a classification regulation for an accessory should be separate from that of the corresponding parent device—a designation typically reserved for accessory types that may be used with multiple parent devices or that have unique standalone functions. However, the FDA recognized that some accessories have a lower risk profile than that of their parent device and, therefore, warrant a lower classification. Section 513(b) of the FDC Act was amended by the 21st Century Cures Act (P.L. 114-255) to reflect that thinking with a category of classification known as de novo classification.

Accessories

After the FDA determines that an article is an accessory, the agency determines whether the article is intended for use with one or more parent devices and then asks whether the article is intended to support, supplement, and/or augment the performance of one or more parent devices. The guidance explains that an article does not become an accessory simply by virtue of the fact that it is used in conjunction with another device. For example, the FDA would not consider a mobile phone to be an accessory merely because it is used as a general platform for applications that include mobile medical applications that are themselves medical devices.

De novo classification

Under Section 513(f)(2) of the FDC Act, the FDA may classify an accessory of a new type under the de novo classification process. Such a classification request is a request for risk- and regulatory control-based classification of a new type of accessory. To fall into the classification of “new category type,” the accessory under consideration should not be previously classified or the subject of any approved premarket approvals (PMAs) or cleared 510(k)s for that accessory type. The de novo classification is intended as a pathway to Class I and Class II device classification for accessories for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, despite the lack of legally marketed predicate device.

Submission and classification

A manufacturer of a medical device accessory, who submits a de novo classification request, must include a description of the device and detailed information regarding the reasons for the recommended classification. The FDA is obligated to make a classification determination for the device, by written order, within 120 days of the request. If the submitter satisfies the regulatory criteria (i.e. presents an accessory for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness) the FDA will grant the de novo request, classifying the new accessory (and new accessory type) as Class I or Class II. The FDA will then publish an announcement in the Federal Register of the new classification and the general and special controls necessary to assure safety and effectiveness for the device type.

SCOTUS denies cert in biosimilar licensing dispute

The Federal Circuit’s decision finding it mandatory that a biosimilar-product applicant give a post-licensure notice to the manufacturer of the original FDA-approved biologic (the reference product sponsor) 180 days prior to beginning commercial marketing will remain law, because the Supreme Court denied a petition for writ of certiorari in Apotex Inc. v. Amgen Inc. A preliminary injunction granted by a district court will remain in effect, despite the biosimilar applicant giving notice to the reference product sponsor of its filing of an application to market the biosimilar (see Biosimilar applicant must give 180-day post-licensure notice to reference sponsor, Health Law Daily, July 6, 2016).

Background

In 2002, Amgen Inc. received a biologics license from the FDA for Neulasta® (pegfilgrastim), a human-engineered protein for patients undergoing chemotherapy. In 2014, Apotex Inc. filed an application for an FDA license to market a biosimilar version of Neulasta, invoking the abbreviated pathway for regulatory approval of follow-on biological products that are highly similar to a previously approved reference product. The abbreviated biosimilar pathway was allowed by the Biologics Price Competition and Innovation Act of 2009 (Biologics Act), which was created by sections 7001-7003 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148).

Under the Biologics Act, a biosimilar-product application may not be submitted until four years after the reference product was first licensed by the FDA and a biosimilar-product license may not be made effective until 12 years after the reference product was first licensed. The Biologics Act also contains detailed requirements that are focused on ways to avoid or streamline potential patent litigation by requiring the exchange of patent information between the biosimilar-product applicant and the reference product sponsor after the FDA accepts the biosimilar-product application for review. Finally, the Biologics Act requires the biosimilar-product applicant to give notice to the reference product sponsor 180-days before commercial marketing of its FDA-licensed product.

After the FDA accepted Apotex’s application for review, Apotex and Amgen engaged in the exchange of patent information as required by the Biologics Act. After negotiations, the parties agreed to an action for infringement of two patents, but after one of the patents expired, Amgen’s patent infringement action against Apotex was only based on the one remaining disputed patent. This appeal, however, did not involve the infringement action but rather Amgen’s motion for a preliminary injunction to require Apotex to provide Amgen notice if and when it receives a license from the FDA and to delay any commercial marketing for 180 days from that notice. The Federal Circuit upheld the injunction and found that giving post-licensure notice to the manufacturer was mandatory.

Supreme Court

In September 2016, Apotex filed a petition for writ of certiorari with the Supreme Court. It requested review of two issues: (1) whether the Federal Circuit erred in holding that biosimilar applicants that make all disclosures necessary under the Biologics Price Competition and Innovation Act for the resolution of patent disputes must also provide the reference product sponsor with a notice of commercial marketing; and (2) whether the Federal Circuit improperly extended the statutory 12-year exclusivity period to 12 1/2 years by holding that a biosimilar applicant cannot give effective notice of commercial marketing for its biosimilar product until it receives a FDA license and therefore may not commercially market its biosimilar product for 180 days after receiving its license. On December 12, 2016, the Court denied Apotex’s petition.

Fraudsters sentenced for various schemes, medical device company settles allegations for $36M

The Department of Justice (DOJ) has continued to crack down on health care fraud in a variety of areas. From a multi-million dollar home health scheme to a mother-son pharmacy fraud team, several perpetrators have been sentenced to prison and ordered to pay restitution for their crimes.

Home health

A Detroit home health care company co-owner was sentenced to 96 months in prison for his part in a fraud scheme. Evidence presented at trial revealed that from 2006 to 2011, he and co-conspirators paid kickbacks to recruiters who passed on cash to patients in order to induce them to sign up for home health care services. Physicians also received kickbacks in exchange for referrals for home health services that were not medically necessary and not provided. This scheme ultimately caused about $33 million in losses to the federal government.

Another co-conspirator was recently sentenced to 360 months in prison for his part in the fraud scheme.

Pharmacy fraud

A mother and son team received prison sentences following their guilty pleas to conspiracy to commit health fraud through their pharmacies. The mother co-owned and operated some Miami-area pharmacies, through which she submitted false and fraudulent claims through Medicare Part D. She led a fraud scheme in which Medicare beneficiaries and patient recruiters were paid for medically unnecessary prescriptions, and various co-conspirators were directed to make kickback payments and conceal fraudulent funds. The son wrote checks to money launderers from the pharmacy in order to facilitate the kickbacks.

In their guilty pleas, the mother admitted that she caused $9.5 million in losses to the government, while the son caused losses of at least $1.5 million. She was sentenced to 120 months in prison, while he was sentenced to 30 months.

Medical devices

Biocompatibles Inc., a medical device manufacturer, pleaded guilty to misbranding an embolic device that was originally designed as a chemotherapy drug delivery device. This device had been cleared for placement in blood vessels to block or reduce blood flow as needed, but was not approved or cleared as a drug-device combination product or a drug-eluting bead. However, Biocompatibles marketed the product for drug delivery for and trained representatives to aggressively penetrate the relevant market. Biocompatibles will pay $36 million to resolve criminal and civil liability, which first stemmed from a qui tam lawsuit brought by a company professional responsible for marketing and management of Biocompatibles’ medical products.

FDA opens portal to future science and tech trends

The FDA is lending additional support behind “horizon scanning,” a practice in which government and business entities collaborate to gather information broadly about emerging trends in science and technology. Horizon scanning helps these entities develop better capabilities to react to the quickly changing field. The FDA set up its own intra-agency horizon scanning group back in April 2015 – the Emerging Sciences Working Group – comprised of representatives from various FDA product and research centers.

Along those lines, the FDA is asking science and technology experts in the private sector to submit predictions on the next “new” items in their field of specialization. The agency stressed that it is not looking for advances already under discussion, but instead is seeking information about scientific and technological advances under the radar–so far under that a web search would have difficultly finding it. The FDA’s ability to achieve its stated agency mission relies on awareness of, and proactive preparedness for, emerging issues and scientific advances, which will impact the development of regulated products well in advance of formal FDA regulatory submissions, which can be anywhere from five to 10 years prior to when the regulatory submissions arrive at the FDA.

The information should be submitted electronically to the FDA’s Emerging Sciences Idea Portal. The portal is public, so confidential information should only be provided in writing. The FDA makes no promises on response, but did note that it would ask for more information if the submission sufficiently interested the agency. The FDA will use this information gathering to assist in the agency’s science-based planning, programs, policies, reporting, and communication within and outside the FDA. The public docket will be available for comment submissions through October 2019.