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.

Industry Insights

PHARMACEUTICALS

FDA Is Cold As Ice As It Steps Up Foreign Inspection Enforcement 
By: Alan G. Minsk 

So far, in 2017, the Food and Drug Administration’s Office of Manufacturing Quality in the Center for Drug Evaluation and Research has released twelve Warning Letters. Of these, 100% involved manufacturing facilities outside the United States; six to Chinese sites, one to a British firm, one to an Italian facility, two to Indian companies, and two to Japanese locations. While it is too early in the year to assess whether this reflects an increased FDA focus on foreign inspections, companies should take note if they have manufacturing sites outside of the U.S. or utilize contract manufacturers in other countries. More >

Let the Sunshine In: Increased Transparency Coming to FDA Advisory Committees
By: Alan G. Minsk and Kalie E. Richardson

Spurred by a challenge from Public Citizen last year, the Food and Drug Administration announced recently that it will no longer redact information from the curricula vitae (CV) of advisory committee members. Current advisory committee members must send updated CVs to FDA, along with an acknowledgment that information in their CV has not been redacted. This shift in policy is a win for advocates who have pushed for transparency of FDA’s decision-making process. More >

MEDICAL DEVICES

Expansion of the Humanitarian Use Device Program under the 21st Century Cures Act 
By: Alan G. Minsk and Kalie E. Richardson

The 21st Century Cures Act, signed into law in December 2016, ushered in a number of changes that will affect the Food and Drug Administration’s product development programs. One such example relates to the expansion of the FDA’s Humanitarian Use Device Program (HUD Program). More >

NEWS FROM WASHINGTON

2017 HIPAA Enforcement: Year to Date Lessons
By: Kevin Coy and Madison M. Pool

With the announcements from OCR of three resolution agreements and one civil money penalty as of mid-February, OCR is off to a record start for HIPAA enforcement in 2017, with double the announcements as the same time last year. Notably, this swift initial series of HIPAA enforcement actions has been announced following—and foreshadows rivaling—what was also a record-setting year for OCR enforcement in 2016. Based on the announcements thus far this year, OCR appears to be continuing its focus on compliance with the HIPAA Security Rule and protection for electronic protected health information (“ePHI”). Covered entities and business associates alike should heed the lessons learned from these announcements and take steps to review their HIPAA compliance and bolster it as necessary. More >