Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice.

Industry Insights

PHARMACEUTICALS

Is Overreporting Adverse Event Information Always In A Company’s Best Interest?
By: Alan G. Minsk

Recently, we moderated a panel at the Food and Drug Law Institute’s Annual Conference, where a senior Food and Drug Administration official participated. The individual from the Center for Drug Evaluation and Research made an interesting comment that many pharmaceutical companies, in his opinion, oversubmit adverse event information they receive during clinical trials. While he recognized the legal obligation to report, when required, he noted that overreporting may be unnecessary and, in fact, counterproductive, as these reports inundate FDA officials, who have to collect and review the data. More > 

OIG Releases Revised Policy Statement on Exclusion Authority 
By: Jennifer D. Burgar

On April 18, 2016, the Office of Inspector General of the Department of Health and Human Services released a revised policy statement on its exclusion authority, entitled Criteria for Implementing Section 1128(b)(7) Exclusion Authority (the “Criteria Statement”). The Criteria Statement, which replaces OIG’s 1997 policy statement, identifies the non-binding criteria to be used by OIG when determining whether to pursue exclusion against a provider or other individual. In contrast to the 1997 policy, the Criteria Statement begins with a presumption of exclusion, and includes a “risk spectrum” for OIG’s use in considering whether that presumption can be rebutted in a particular matter. More >

FDA Talks Generic Drugs: A Look at the Generic Drug Approval Process from the Agency’s Perspective
By: Alan G. Minsk and Cathy M. Fortney

So you’re preparing an abbreviated new drug application submission… what could possibly go wrong? The Food and Drug Administration responds: Let us count the ways… However, much of it can be avoided if one merely knows where to find help, said experts from the FDA’s Office of Generic Drugs recently at the Generic Drugs Forum 2016. This two-day conference, which AGG attended, was intended to inform small business generic drug companies of the importance of getting ANDA submissions on track right out of the gate, and keeping them on track throughout the entire review process. Knowing what needs to be included in the ANDA submission (and what to keep out), as well as knowing what one can and cannot do during the review process, is critical to the success or failure of the application. More >

MEDICAL DEVICES

Wave of the Future: Government Releases New Tool to Aid Medical App Developers Comply with HIPPA
By: Kara B. Gordon

This month, the Department of Health and Human Services, the Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and the Federal Trade Commission released an interactive tool entitled the “Mobile Health Apps Interactive Tool.” The tool is designed to help medical mobile app developers identify the federal law(s) that apply to collecting, storing, and sharing individually identifiable consumer health information.  More > 

FOOD

FDA Releases (an Updated) Guidance on Medical Foods: What They Are, And What They Are Not
By: Alan G. Minsk, Alan K. Parver and Leah M. Stone

The Food and Drug Administration recently released its Second Edition of its “Guidance for Industry: Frequently Asked Questions About Medical Foods.” The newer version updates previous guidance and provides responses to questions regarding the definition and labeling of medical foods and updates to some of the existing responses. While the guidance is not legally binding on FDA or industry, it offers insights into current agency thinking.  More >

NEWS FROM WASHINGTON

Pharmaceutical Company Reaches Preliminary Agreement in Principle to Resolve DOJ and SEC Investigations
By: Sara M. Lord, Alan G. Minsk and W. Jerad Rissler

On May 12, 2016, Aegerion Pharmaceuticals, Inc., announced that it has reached “preliminary agreements in principle” with the Department of Justice and the Securities and Exchange Commission to resolve the agencies’ investigations into its sales activities and public statements regarding Juxtapid, a drug in capsule form, which is used to treat a rare form of high cholesterol and costs about $250,000 a year. More >

Implied Fraud Under the False Claims Act Hangs in the Balance
By: Sara M. Lord and Kara B. Gordon

On April 19, 2016, the United States Supreme Court heard oral arguments in a hotly anticipated False Claims Act case: Universal Health Services, Inc. v. United States ex rel. Escobar. The Court will decide whether the “implied certification” theory is a valid basis for finding contractors and providers liable under the FCA. Under this theory, which has been adopted by First, Second, Third, Fourth, Sixth, Ninth, Tenth, Eleventh, and D.C. Circuits, claims may be considered false or fraudulent on the basis that they include the implicit representation that the provider has complied with all conditions of payment. As a basis for legal falsity under the FCA, the implied certification theory exposes contractors and providers to significant damages and potential exclusion from government programs for failing to comply with a wide array of regulations, many of which are not immediately apparent. The Court’s decision will have significant consequences for contractors, as there likely will be exponential growth in the number of qui tam suits filed if the Court upholds “implied certification” as a basis for legal falsity. Alternatively, if the Court rejects this theory, many currently pending FCA complaints are likely to be dismissed. More >