Arnall Golden Gregory LLP's 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.

In this Issue

• Come on People Now ... Everybody Get Together, Try to Love One Another: FDA Issues Final Guidance on Quality Agreements
• Thanks to 21st Century Cures, the Sun is Coming out Tomorrow for Orphan Drugs and Pediatric Priority Review Vouchers
• FDA Issues Draft Guidance on 510(k) Third Party Review Program
• 21st Century Cures Act Brings New Research Funding and Changes to the FDA
• Show Me, Show Me, Show Me: FDA to Post Adverse Event Report Data Associated With Certain Products
• One Step Up: U.S. Export Controls for Pharma/Device Companies
• HHS OCR Levies Significant HIPAA Penalties in a Series of Recent Settlements: Covered Entities and Business Associates Alike Should Review Practices
• Industry Activities and Recognition

PHARMACEUTICALS

Come on People Now ... Everybody Get Together, Try to Love One Another: FDA Issues Final Guidance on Quality Agreements
By: Alan G. Minsk

Three and a half years after issuing its draft guidance, on November 22, 2016, the Food and Drug Administration released its final guidance, “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance is not legally binding on industry or FDA and it is limited to human drug, biologic, and veterinary drug companies. However, all FDA-regulated industries should review the guidance, because it reflects the agency’s current thinking on the value of quality agreements and its expectations. The guidance is also useful in that it attempts to offer recommendations to industry to minimize quality surprises and to maximize regulatory compliance by building quality into the process early and often. Channeling the Youngbloods 1967 hit, “Come Together,” FDA encourages everyone to “come on people now,” to “get together,” and “to love one another.” This Bulletin summarizes some of the guidance’s key elements and recommendations. We will also offer our own observations. More >

Thanks to 21st Century Cures, the Sun is Coming out Tomorrow for Orphan Drugs and Pediatric Priority Review Vouchers
By: Alan G. Minsk and Kalie E. Richardson

The 21st Century Cures Act, a bill that includes major Food and Drug Administration reform, was passed by the Senate last week and was signed by President Obama on Tuesday, December 13, 2016. While the new law addresses a wide variety of areas related to FDA regulation, it also includes an amendment to the Orphan Drug Act and reauthorization of the priority review voucher program for rare pediatric diseases. More > 

MEDICAL DEVICES

FDA Issues Draft Guidance on 510(k) Third Party Review Program
By: Kelley C. Nduom and Kalie E. Richardson

The Center for Devices and Radiological Health (CDRH) recently issued a draft guidance on the 510(k) Third Party (TP) Review Program. The TP Review Program (formerly known as the Accredited Persons Program) allows FDA to authorize third party organizations to review certain 510(k) submissions and issue initial classification determinations. The reviewers then forward their recommendations to FDA for a final determination of substantial equivalence. The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in 2012, required that FDA create accreditation criteria for third party review organizations; this draft guidance establishes the criteria mandated by FDASIA. A second purpose of the draft guidance is to encourage harmonization between the TP Review Program and the international standards established by the International Medical Device Regulator Forum’s Medical Device Single Audit Program. More >

21st Century Cures Act Brings New Research Funding and Changes to the FDA
By: Joseph S. Rubin and Kalie E. Richardson

Last week the Senate passed, nearly unanimously, the 21st Century Cures Act, which President Obama signed on December 13, 2016. The Act is divided into three divisions: 21st Century Cures, Helping Families in Mental Health Crisis, and Increasing Choice, Access, and Quality in Health Care for Americans. The first and primary division includes a slew of additional funding in various areas for public health and research initiatives, and significant regulatory changes to the FDA. The National Institutes of Health will receive over $4.7 billion from 2017 to 2026 tied to three main projects: Precision Medicine, BRAIN Initiative, and Cancer Moonshot. An additional $1 billion will also be available over the next two years for state response to the ongoing opioid abuse crisis. More >

FOOD

Show Me, Show Me, Show Me: FDA to Post Adverse Event Report Data Associated With Certain Products
By: Alan G. Minsk and Elizabeth A. Mulkey

On December 7, 2016, the Food and Drug Administration announced that it would post on its website adverse event reports from January 2004 to the present for food (including food additives, color additives, and dietary supplements) and cosmetics. These products are regulated by FDA’s Center for Food Safety and Applied Nutrition. Depending on the type of product and adverse event, some reports are mandatory and others are voluntary. Previously, to obtain this information one had to submit a request under the Freedom of Information Act, which we know can take months, if not years. FDA hopes that the posting will provide transparency about adverse event reports and improve public health by identifying possible risks with a particular product. More >

NEWS FROM WASHINGTON

One Step Up: U.S. Export Controls for Pharma/Device Companies
By: Michael E. Burke

2016 was an active year for U.S. export control developments impacting U.S. pharma/device companies. We expect 2017 also to be busy, especially with the upcoming change in Administrations. This article briefly will review for U.S. pharma/device companies (i) relevant, but general, changes to U.S. export controls; (ii) changes to the Cuba sanctions program; and (iii) changes to the Iran sanctions program. The article also will—very briefly—try to divine potential changes to those programs that may be implemented in 2017. More >

HHS OCR Levies Significant HIPAA Penalties in a Series of Recent Settlements: Covered Entities and Business Associates Alike Should Review Practices
By: Kevin Coy

Between June and November 2016, the Department of Health and Human Services Office of Civil Rights (HHS OCR) has announced seven high-dollar settlements to resolve alleged violations of the HIPAA privacy, security, and breach notification rules by both covered entities and business associates. Penalties ranged from $400,000 to $5.5 million (the largest HIPAA settlement to date against a single entity). In addition to announcements that OCR intends to increase scrutiny of data breaches involving fewer than 500 individuals and HHS OCR’s ongoing HIPAA audit program, these settlements underscore the importance of HIPAA compliance both for covered entities and for business associates. More >

Alan Minsk Named to Who's Who

Alan G. Minsk was recently named as a Who’s Who among regulatory attorneys in the 2017 Life Sciences edition. Since 1996, Who's Who Legal has identified the foremost legal practitioners in 34 areas of business law in more than 100 countries. More >

AGG Partner Discusses U.S. Drug Companies Investigated for Price Collusion

AGG Partner Jeffrey S. Jacobovitz and David McLaughlin, a reporter for Bloomberg News, discussed an investigation into whether drug companies are colluding to fix prices of generic drugs. They spoke with Bloomberg’s Greg Stohr and Michael Best on Bloomberg Radio’s "Bloomberg Law." More >

AGG Attorneys Present Complimentary Webinar on FDA’s Recent Enforcement in Product Promotional Arena

AGG Attorneys Alan G. Minsk and Kelley C. Nduom presented the complimentary webinar “What a Long Strange Trip It’s Been: FDA’s Recent Enforcement in the Product Promotional Arena (and Where we Might be Headed)” on November 29, 2016. Recording and presentation information available upon request. More >

Happy Holidays from Arnall Golden Gregory's
Food and Drug Practice Team!