FDA-Regulated Entities: Compliance and Enforcement Strategies Introducing the FDA Deskbook: A Compliance and Enforcement Guide
Presenters Jennifer D. Newberger helps medical device clients develop regulatory strategies, prepare product applications, comply with labeling, advertising, and promotion, and address enforcement actions. Before joining the firm, Ms. Newberger was a policy advisor at FDA's Center for Devices and Radiological Health. Jennifer M. Thomas is an associate at Hyman, Phelps & McNamara, P.C., and works primarily on government investigations, civil and criminal litigation, and enforcement matters. She assists FDAregulated companies with managing responses to warning letters, subpoenas, civil investigative demands, and proposed consent decrees. Anne K. Walsh is a director at Hyman, Phelps & McNamara, P.C., and counsels clients on compliance and enforcement issues, including FDA inspections, seizure and injunction actions, warning letters, and recalls. She defends companies facing criminal and/or civil investigations for allegations of marketing and promotion fraud, and cgmp, QSR, and health care violations. Before joining the firm, Ms. Walsh served as Associate Chief Counsel with FDA s Office of Chief Counsel. 2
Overview Case study Complying with FDA s regulations Best practices for addressing a whistleblower allegation and corresponding internal investigation Handling an FDA inspection Assessing potential enforcement action 3
Hypothetical VersaGraft is a manufacturer of catheters. In April 2015, the company began to receive reports that one of its products, the PrimoGraft, contained dust, spores, and other weird little things when opened in the operating room. 4
Hypothetical (cont.) In response, the company took the following steps: The company investigated and found that the products were being improperly packaged and that many of the packages were not actually sealed. The problem was traced to poor equipment, compounded by faulty employee training. The company temporarily stopped shipping PrimoGraft while it investigated and fixed the problem. Validation tests for the new seal on the product were successfully completed six weeks after shipping resumed. Was the company s response appropriate? 5
Complaint Handling Appropriately document and investigate each complaint If the complaint trend shows a potential quality problem, open a CAPA Review for MDR reporting Discussed in detail in Chapter 9, 9:11 6
CAPA Key Steps to CAPA Correction Inspect existing stock Consider whether to recall the product Review new complaints to assess rate of occurrence, new root cause, change in field action decision Corrective Action Fix problem so it cannot recur in future (e.g., revise procedure) Consider supplier issues Preventive Action Review similar products and/or procedures that may have same root cause Effectiveness Check Have the actions been verified/validated to be effective and not adversely affect device? Discussed in detail in Chapter 9, 9:8 7
Hypothetical (cont.) The company immediately conducted a market withdrawal, and successfully retrieved most of its product (117 out of 129 accounts). For the unaccounted product, there were no reports of injury. VersaGraft called this action a market withdrawal, and did not notify FDA of the action. Would FDA agree with the decision to classify the action as a market withdrawal? 8
Market Withdrawal What is a market withdrawal? A correction or removal of a distributed device which involves a minor violation of the act that would not be subject to legal action by FDA or that involves no violation, for example, normal stock rotation practices. Notification to FDA Discussed in Chapter 10: 9
Hypothetical (cont.) In February, a healthcare facility reported that a patient had been injured by a PrimoGraft, causing serious infection and requiring hospitalization of the patient. A nurse stated there had been lots of problems during the operation and doubted that the PrimoGraft had anything to do with the patient s condition. VersaGraft believed the doctor was always whining and exaggerating. No MDR was filed. Would FDA agree with the decision not to submit an MDR? 10
Medical Device Reports What is a reportable event? An event that manufacturers become aware of that reasonably suggests that a device: May have caused or contributed to a death or serious injury; or Has malfunctioned and this device or a similar device would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. Timing for submitting reports Discussed in detail in Chapter 11 (provided with your registration materials) 11
Hypothetical (cont.) Last week, VersaGraft received a report from a PrimoGraft distributor that a nurse at a hospital customer opened a carton containing PrimoGraft and found it disgusting with gross contamination. The distributor would not release the name of the hospital. VersaGraft conducted a quick review of the production records and found nothing unusual except for the notation that there had been some kind of problem which was fixed with the packaging equipment. No details were given in the device history record. What should the company do? 12
Internal Investigations Last month, the company s legal counsel received an anonymous telephone call alleging that the company s quality control manager was incompetent, spiteful, and sloppy with "paperwork. The company s quality control manager has been working at the company for twenty-five years. She manages 20 employees, and there has been significant turnover in her group in the last two years. What should the company s legal counsel do with this information? 13
Internal Investigations Detailed in Chapter 20 (provided with registration) Documenting the complaint Initiating an investigation Conducting an investigation Documenting the investigation Remediation, if necessary 14
Internal Investigations The company retains outside counsel to conduct a full investigation. The investigation concludes that there is no merit to the allegations, and that the anonymous call was from a jilted ex-boyfriend of the QC manager. The company counsel prepares a written report documenting the privileged investigation. Should the company voluntarily disclose this information to the government? 15
Internal Investigations Self-Disclosure Mandatory reporting Voluntary reporting Pros: Get ahead of situation Cooperation credit Reputational benefit Cons: Trigger attention from government, lawsuits Reputational harm Detailed in 20:8.4 16
FDA Inspection Yesterday, FDA investigators arrived at the VersaGraft facility for an inspection. They immediately ask to speak to the quality control manager in private. Can the company refuse to make her available to FDA for this interview? See 21:2.5. 17
FDA Inspection The company offers, and the FDA investigators agree, to go on a tour of the facility. On that tour, one of the FDA investigators begins to snap pictures of the manufacturing lines. As they walk through the quality control laboratory, one of the investigators uses his iphone to take photos of the lab books at one of the stations. He asks the company to make complete copies of the lab notebooks for the last two years. Does FDA have authority to take photos and take copies of these records? 18
FDA Inspection It is obvious to the company that the FDA investigators have received the same allegation the company received about the QC manager. Should the company offer the results of its internal investigation? 19
FDA Inspection At the end of each day, the company holds a mini-closeout with the FDA investigators. FDA previews the scope of the inspection for the following day. After five full days on site, FDA states that they will hold a close-out meeting the following day. Who should attend that meeting? What sort of documentation should the company expect from FDA? Should the company sign affidavits at the end of the inspection? 20
FDA Inspection FDA issues a Form 483 with 4 observations relating to the company s failure to submit MDRs. How should the company respond to the 483? Timeline Tips for success 21
FDA Administrative Actions Inspections and 483s Warning and Untitled Letters Recalls Import Detentions Administrative Detentions Clinical Holds Application Integrity Policy Civil Monetary Penalties Disqualification of Clinical Investigators Debarment Publicity 22
Civil Enforcement Actions Seizures Injunctions Legal Authority Types of Injunctions Procedures for Initiating an Injunction Action Defending Against an Injunction Action Consent Decree Provisions Vacating an Injunction 23
Criminal Prosecution FDC Act Strict Liability Criminal Violations Felony Violations Title 18 Alternatives Mail Fraud and Wire Fraud Criminal Conspiracy RICO Health Care Fraud False Statements Obstruction of Justice 24
Questions? 25