Owner of compounding company at the center of the 2012 meningitis outbreak acquitted of murder

A Boston jury convicted Barry Cadden, the owner and head pharmacist of the New England Compounding Center (NECC), of racketeering and mail fraud in connection with the 2012 nationwide fungal meningitis outbreak but acquitted him of 25 second-degree murder charges. His sentencing is scheduled for June 21, 2017; he faces a statutory maximum sentence of up to 20 years’ imprisonment on each of the mail fraud and racketeering counts.

Outbreak. In September 2012, the Centers for Disease Control and Prevention (CDC) began investigating a multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free methylprednisolone acetate (MPA) steroid injections from NECC. The CDC reported that 753 patients in 20 states were diagnosed with a fungal infection after receiving injections of NECC’s MPA. Of those 753 patients, the CDC reported that 64 patients in nine states died.

Indictment. In December 2014, the U.S. Attorney’s Office in Massachusetts announced a 131-count federal criminal indictment in connection with the outbreak. Cadden and NECC’s supervisory pharmacist, Glenn A. Chin, were charged with 25 acts of second-degree murder in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia. Twelve other individuals associated with NECC, including six other pharmacists, the director of operations, the national sales director, an unlicensed pharmacy technician, two of NECC’s owners, and one other individual were charged with additional crimes.

Prosecutors alleged that Cadden directed and authorized the shipping of contaminated MPA nationwide. In addition, he authorized the shipping of drugs before test results confirmed their sterility, failed to notify customers of nonsterile results, and compounded drugs with expired ingredients. NECC also used fictional and celebrity names on fake prescriptions to dispense drugs.

 

FDA considers establishing a new ‘Office of Patient Affairs’

The FDA announced that it is establishing a public docket to solicit public input on ongoing efforts to enhance mechanisms for patient engagement at the agency. In addition, to achieve a more transparent, accessible, and robust experience for patient communities, the FDA is considering establishing a new Office of Patient Affairs.

On November 4, 2014, the FDA established a docket (FDA-2014-N-1698) for the public to submit information related to the FDA’s implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144), Patient Participation in Medical Product Discussions under FDASIA section 1137.

Based on the comments received, the FDA identified objectives for its patient engagement activities. First, to develop a nuanced understanding of the patient experience of disease by: (1) gathering patient perspective on what is clinically meaningful; (2) assessing attitudes towards benefit-risk and tolerance of uncertainty; and (3) enhancing the science of eliciting and integrating patient input.

Second, to support patients and their advocates in understanding regulatory processes and navigating the FDA by: (1) communicating relevant FDA positions, procedures, and activities; (2) connecting patients and their advocates with the appropriate resources; and (3) resolving discrete challenges and needs.

To achieve these objectives, the FDA is considering establishing a central “Office of Patient Affairs.” The responsibilities of this central office would include:

  • offering a single, central entry point to the FDA for the patient community;
  • providing triage and navigation services for inbound inquiries from patient stakeholders;
  • hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with the FDA by patient stakeholders and the FDA’s relationships with patient communities; and
  • developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels.

The Office of Patient Affairs would be directly accountable to the medical product Centers. A regular evaluation of this central office and of FDA’s overall patient engagement efforts are also proposed.

 

 

Biosimilar dispute headed to the Supreme Court

Biosimilar manufacturers will soon have a definitive answer on the timing of giving notice of commercial marketing, thanks to the Supreme Court. On January 13, 2017, the Court granted and consolidated Sandoz, Inc.’s petition for writ of certiorari and Amgen, Inc.’s conditional cross-petition for writ of certiorari. The dispute appeals the Federal Circuit’s July 21, 2015 decision holding that Amgen was entitled to an additional 180-day marketing exclusivity period because of Sandoz’s late notification of its intention to market a biologic product that is biosimilar to Amgen’s Neupogen® (see Court interprets biosimilar ‘enigma’ in favor of abbreviated biologic license applicant, Health Law Daily, July 22, 2015).

The Court also granted Apotex, Inc.’s motion for leave to file a brief as amici curiae; Apotex was involved in a similar dispute with Amgen (see Biosimilar applicant must give 180-day post-licensure notice to reference sponsor, Health Law Daily, July 6, 2016), though the Court denied Apotex’s petition for writ of certiorari earlier this term (see SCOTUS denies cert in biosimilar licensing dispute, Health Law Daily, December 12, 2016).

The Biologics Price Competition and Innovation Act (BPCIA), which was passed in 2010 as sections 7001-7003 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), created an abbreviated pathway for FDA approval of a “biosimilar” biologic product. Amgen originally brought suit against Sandoz in federal court asserting various violations of Amgen’s approved license for its cancer-fighting biologic Neupogen (filgrastim) and infringement of Amgen’s patent for a particular method of using filgrastim. The Court will be hearing arguments relating to Sandoz’s question regarding the 180-day notice of commercial marketing and Amgen’s cross-petition on the optionality of a process to settle patent disputes known as the “patent dance” (see Shall we dance? Biosimilars step toward new legal and regulatory future, Health Law Daily, March 31, 2016).

Makeup of the Court

Since the February 13, 2016, death of Justice Antonin Scalia, there have been eight Justices sitting on the Court. President Barack Obama’s nominee to replace Scalia, D.C. Court of Appeals Chief Judge Merrick Garland, was not considered by the Senate; President-elect Donald Trump plans to nominate a successor early into his term. In order to receive a vote in cases pending before the Court, a Justice must be seated on both the day of the oral argument and the day the written decision is released. Trump’s nominee will only be part of the decision if he or she is confirmed and duly sworn in before the oral arguments, which are not yet scheduled.

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.