FDA Update on Consent Decrees and Criminal Prosecutions | Sheldon Bradshaw | Archived Recording

FDA Update on Consent Decrees and Criminal Prosecutions | Sheldon Bradshaw | Archived Recording

October 21st, 2013 // 5:59 pm @

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FDA has been enforcing cGMP guidelines for drugs and medical devices more strictly than ever in recent years. One of the ways it is increasing enforcement is through the issuance of consent decrees. Former FDA Chief Counsel Sheldon Bradshaw provides an update on FDA’s more aggressive stance on consent decrees and criminal prosecutions.

Agenda of This Webinar:

  • Basic violations of the Food, Drug and Cosmetic Act.
  • Current enforcement atmosphere at FDA.
  • FDA’s enforcement authorities.
  • Seizures
  • Injunctions/Consent Decrees
  • Criminal Prosecutions/Individual Liability

Violations of the Food and Drug Act:

  • Any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the condition prescribed, recommended, or suggested in the labeling thereof; or
  •  Any drug the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

Current enforcement atmosphere:

  • The new Commissioner of the U.S. Food and Drug Administration, Dr. Margaret A. Hamburg, recently declared that she wants to “pump up enforcement” at FDA.  See FDA Commissioner Faces Formidable To-Do List, Wash. Post (6/17/2009).
  • Commissioner Hamburg further explained that, under her leadership, the FDA would change its enforcement “posture to one that is more aggressive and forward leaning.”  See id.
  • Commissioner Hamburg promised swift, aggressive, and effective enforcement of FDA laws and regulations “to prevent harm to the American people.” See Effective Enforcement and Benefits to Public Health, Speech at FDLI (8/6/2009).
  • Dr. Hamburg:  “We must get the word out that the FDA is on the job.”  See id.

According to Deborah Autor, Director of CDER Office of Compliance:

  • In today’s rapidly changing environment, complacency is not an option.  I do predict more action.  Tell your clients and companies to get going.”  See FDA Ups the Ante in Enforcement, Pink Sheet (5/18/2009)
  • You can wait for me to take action, but I would say don’t wait.  Every drug without FDA approval is subject to action.  All of them are priorities.  We will not tell you what is next.”  See id.
  • Companies must strictly adhere to legal requirements designed to protect product quality and integrity.  All parties involved in the drug lifecycle must recognize that they have an ethical liability.”  See id.
  • CDER Compliance is also looking at a firm’s overall ability to meet FDA requirements as a possible indicator of whether the firm should be a compliance concern.  For example, her office is noticing that poor quality of applications for FDA approval of drugs or faulty Adverse Event Report systems tend to show a likelihood of poor compliance in other areas, such as cGMPs.  See FDLI Speech (10/13/2009).

Commissioner’s Pledge to Increase Criminal Prosecutions of Corporate Officers:

  • Dr. Hamburg has called for more frequent prosecutions of “responsible corporate officers” under the FD&C Act.
  • Under the responsible corporate officer doctrine, also known as the Park doctrine, senior individuals in FDA-regulated companies can be charged with strict-liability misdemeanor offenses even when the individuals did not participate in, or even know about, the underlying misconduct.
  • Individuals convicted of strict-liability misdemeanor offenses face imprisonment, substantial criminal fines, debarment and, potentially, lengthy exclusions from federal health programs.

About the Presenter:

In October 2007, Sheldon Bradshaw joined Hunton & Williams LLP as a partner and co-chair of the firm’s Food and Drug Practice Group. Mr. Bradshaw came to the firm from the U.S. Food and Drug Administration (FDA), where he served as Chief Counsel. As Chief Counsel, Mr. Bradshaw was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA’s senior leadership – including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers – on issues related to drugs, biologics, medical devices, food, animal feed and drugs, cosmetics, dietary supplements and other products regulated under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. In addition, he oversaw all FDA-related litigation and reviewed and approved every significant regulation and guidance document promulgated by the FDA and every significant warning letter issued by the FDA.

Prior to his service at the FDA, Mr. Bradshaw held several senior positions at the U.S. Department of Justice where he, among other things, provided advice to FDA and testified before Congress on matters under the FDA’s jurisdiction. At the firm, Mr. Bradshaw advises clients in the same areas in which he worked while Chief Counsel of FDA.






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