Food & Drug Regulation

FDASIA: Its Meaning and Impact

Presented by Daron Watts, Peter Goodloe, Neeraj Pai
Recorded On: Thursday, September 20, 2012
Duration: 90 minutes
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Register now for this 90-minute webinar to learn about the FDA’s new powers under FDASIA, the new regulatory requirements that companies face under the statute and issues that the statute presents, including unresolved questions and potential directions where the statute may lead the agency and the industry.


On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA).  The statute includes the reauthorization bills for the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) while also establishing user fees for generic drugs and biosimilars.  However, other elements of the legislation impose new registration and notification requirements on industry, while providing the agency with additional enforcement tools to deal with issues such as the safety of the drug supply, counterfeit drugs, and drug shortages.  At the same time, while the statute did not include a long-expected section to provide for the tracking and tracing of pharmaceutical products, Congress continues to consider additional legislation mandating such a system for the near future. 

Register today to hear industry experts Daron Watts (moderator), Raj Pai, and Peter Goodloe of Sidley Austin, LLP, discuss FDASIA’s new requirements and the potential impact the statute may have from a compliance perspective. The webinar will also focus on areas where the agency will issue regulations, as well as areas where interim agency guidance may be necessary before compliance can be ensured, the potential for follow-on legislation and the issue of FDA’s appropriations budget and how that might impact enforcement.

Key Discussion Points:

  • The requirement for risk-based inspection frequency and FDA’s new ability to enter into arrangements to recognize foreign government inspections to help meet this requirement.
  • The agency’s new powers to demand records in advance or in lieu of an inspection, and the implications of a new statutory prohibition against delaying, denying, limiting, or refusing an inspection.
  • The broad new notification requirement for regulated persons to notify the agency about potential problems from drugs, including the risk of death from a drug, thefts of drugs, and/or counterfeiting of drugs.
  • The expanded penalties applicable and new standard that applies to certain acts of intentional adulteration of drugs.
  • The enhancements to penalties applicable under Title 18 related to counterfeit drugs and the mandate for the Department of Justice to give priority to such investigations.
  • The explicit grant of extraterritorial jurisdiction to FDA and the implications of this provision.
  • The drug shortage reporting requirements and the implications of requirements imposed on FDA to internally evaluate drug shortage issues in making enforcement decisions.
  • The provisions allowing for administrative detention of drugs, and the need to monitor the agency’s forthcoming regulations implementing these provisions.
  • The agency’s increased ability to share and exchange confidential information with foreign regulatory authorities.
  • The expansion/clarification of the statutory definition of “current good manufacturing practice”.
  • The registration requirements for commercial importers and the associated prohibited acts.
  • The potential for track and trace legislation and what it may require in the future.

Register today to learn about the key issues surrounding FDASIA so that you will have an understanding of how it impacts your company’s compliance plans.

Daron Watts
DARON WATTS practices at the crossroads of law and public policy, providing strategic counsel to clients facing complex challenges which involve issues relating to government regulation and public policy, including investigations, legislation and litigation. Mr. Watts is a leading architect of Sidley Austin’s Government Strategies practice and leads the Health Policy team. In 2008, Mr. Watts was named to the Daily Journal’s “Top 20 under 40,” which recognizes California’s top lawyers under the age of 40.

Mr. Watts’ multidisciplinary background – from his experience with litigation and regulatory/enforcement matters to his work on legislative, oversight and public policy matters – offers unique value to clients who must manage complex business challenges on multiple fronts. This experience adds unique perspective to his strategic advice regarding the manner in which various institutions, including different branches of government, the private sector and non-profit entities, and events interrelate and impact law and policy.

His practice has focused primarily on the representation of FDA-regulated entities. He works routinely in the three branches of the U.S. government with leaders who shape law and policy, including regulators, Members and staff on Congressional Committees with jurisdiction over health policy and oversight/investigations, and industry and non-profit leaders in healthcare.

His regulatory and enforcement practice has focused on matters relating to development, manufacturing and marketing of FDA-regulated products, including food, nutritional supplements, drugs, devices and biologics. Mr. Watts also has represented clients in a wide variety of civil, criminal, and regulatory/compliance matters, including investigations involving the U.S. Congress, the Department of Justice, and the Government Accountability Office (GAO) as well as various state Attorneys General.

Peter Goodloe
PETER M. GOODLOE, counsel in Sidley Austin's Washington, D.C., office, concentrates his practice on FDA and healthcare law, public policy, and a variety of legislative matters – including climate change and environmental issues. He joined Sidley after serving as a counsel in the House of Representatives for over 23 years; for many of those years he worked as one of the principal health care and FDA attorneys in the House Office of Legislative Counsel. For 14 years, he was an adjunct professor at George Washington University School of Law, where he taught legislative analysis and drafting.

During the 110th Congress, Mr. Goodloe served the Chairman of the House Energy and Commerce Committee as one of the principal managers of the staff of the Committee. As the legislative counsel and parliamentarian for the Committee, he helped draft the Food and Drug Administration Amendments Act of 2007 and was one of the key architects of the strategy for moving the legislation through the House. Mr. Goodloe also made contributions that helped facilitate the enactment of a number of additional legislative initiatives, including the Genetic Information Nondiscrimination Act of 2008 and the Charlie W. Norwood Living Organ Donation Act. In his capacity as parliamentarian, he became intimately involved in all procedural issues falling under the jurisdiction of the Committee and dealt extensively with House leadership and many other committees in the House. Mr. Goodloe is widely known for his expertise in legislative drafting and interpretation of statutory provisions.

While serving in the House Office of Legislative Counsel, Mr. Goodloe advised Members and staff on matters concerning the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and other public health agencies within the Department of Health and Human Services. He helped draft landmark legislation such as the National Institutes of Health Reform Act of 2006; the Ryan White HIV/AIDS Treatment Modernization Act of 2006; the Combat Methamphetamine Epidemic Act of 2005; the Project BioShield Act of 2004; the Medical Device User Fee and Modernization Act of 2002; the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; the Food and Drug Administration Modernization Act of 1997; the Food Quality Protection Act of 1996; and the National Institutes of Health Revitalization Act of 1993.

Mr. Goodloe also was deeply involved in the 2003 amendments to the Hatch-Waxman program for generic drugs. He was one of the principal drafters of the legislation that created the Ryan White HIV services program in 1990 and was significantly involved in writing the Disadvantaged Minority Health Improvement Act of 1990. In addition, he helped craft legislation that established the Substance Abuse and Mental Health Services Administration in 1992 and the Agency for Healthcare Research and Quality in 1989.

Neeraj Pai
NEERAJ D. PAI is counsel in Sidley Austin, LLP's Food, Drug and Medical Device Compliance and Enforcement Practice. His practice focuses on representing life science companies in connection with government investigations, enforcement proceedings, and litigation. These investigations and enforcement proceedings involve a range of matters including marketing practices, product safety and reporting, good manufacturing practices, and civil and criminal violations of the Federal Food, Drug, and Cosmetic Act (the “FDCA”).

Prior to joining Sidley, Mr. Pai worked in the FDA’s Office of Chief Counsel from 2008 to 2012. During his tenure, he worked closely with the FDA’s Office of Criminal Investigations (OCI), the Department of Justice, and other federal agencies responsible for investigating, prosecuting, and resolving criminal enforcement actions and related civil False Claims Act cases involving drugs, medical devices, and biological products. Mr. Pai has experience handling cases involving a wide array of issues, including marketing and promotional activities, reporting obligations, import issues, unapproved new drugs, adulterated food products, reporting requirements, smuggling, and fraud.

During his time at FDA, Mr. Pai was appointed as a Special Assistant United States Attorney by the Department of Justice, and assisted in the indictment and successful prosecution of cases at both the federal and state level involving adulterated and misbranded foods, drugs, devices, dietary supplements, and cosmetics. These cases included both felony and misdemeanor prosecutions under the FDCA. Mr. Pai also worked closely with field agents from OCI, the Federal Bureau of Investigation, U.S. Immigrations and Customs Enforcement, and other federal and state law enforcement agencies during the course of criminal investigations. In addition, Mr. Pai developed training materials and taught courses on food and drug law to OCI Agents.

Before entering government, Mr. Pai worked in private practice in Washington, D.C., representing individuals and Fortune 500 corporations in a variety of matters, with a focus on tax controversy, transfer pricing, government investigations, and internal investigations.