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
Industry Insights
PHARMACEUTICALS
Spelling Counts (Among Other Things): FDA Issues Warning Letters for Mistakes in Drug Listing
By: Deborah L. Livornese and Alan G. Minsk
Recently, the Food and Drug Administration issued two Warning Letters to pharmaceutical companies for failing to fulfill product listing obligations for what appear to be oversights. In the first letter issued at the end of April, FDA said the lists of active ingredients in the product listing and in the product labeling did not match. The listing included an active ingredient not found in the product labeling, and the product labeling contained an active ingredient not found in the listing. The agency also noted and requested correction of a spelling error in one of the ingredients. In the second letter, issued June 1, FDA again found a discrepancy between the active ingredients in a product label and in the listing information. More >
All or Nothing at All: Brexit Update for Life Sciences Companies
By: Michael E. Burke
A lot of ink has been spilled in projecting what Brexit (the UK’s withdrawal from the European Union) might look like, including in this space by this author. The simple fact is that we don’t know what Brexit will actually look like--especially after last week’s UK elections. However, we’re aware of some areas of concern that should be monitored by US life sciences companies. More >
When FDA Says, “It Ain’t Good Enough” – Rare Litigation over Pediatric Exclusivity
By: Deborah L. Livornese and Kalie E. Richardson
Well, the other Boss, Bruce Springsteen, not FDA, used those words. When FDA said essentially the same thing less lyrically, but with better grammar, Amgen initiated a lawsuit on May 25, 2017, over an infrequently litigated piece of food and drug law: pediatric exclusivity. More >
FDA Says Viewers Catch a Fleeting Glimpse; Can’t Hear What You’re Saying to Sponsor of Ad with Mismatched Audio and Visual Risk Information
By: Deborah L. Livornese and Elizabeth A. Mulkey
Recently, FDA’s Office of Prescription Drug Promotion (OPDP) issued its first Untitled Letter of the year, citing a direct-to-consumer TV advertisement for a prescription weight- loss drug. According to OPDP, the ad made false or misleading representations about the risks associated with the drug, thus misbranding the product. Notably, the ad provided safety information about the drug, but the agency took issue with the way this information was presented. More >
NEWS FROM WASHINGTON
Not Another Brick in the Wall
By: Michael E. Burke
On June 5, 2017, Saudi Arabia, Bahrain, and the United Arab Emirates cut diplomatic ties with, and imposed an economic embargo on, Qatar. U.S. life sciences companies should be mindful that support for or compliance with this economic embargo against Qatar could violate U.S. law. More >
$387,200 Fine from HHS OCR for the Improper Disclosure of PHI to an Employer and an Volunteer Organization
By: Kevin Coy
On May 23, 2017, the Department of Health and Human Services Office of Civil Rights (HHS OCR) announced a settlement with St. Luke’s-Roosevelt Hospital Center, part of the Mount Sinai Health System, to resolve allegations that protected health information (PHI) had been improperly been disclosed to a patient’s employer in one case, and a volunteer organization in another incident. More >
HHS OCR Resumes HIPAA Enforcement Action Announcements: Four New Settlements and Penalties Totaling More than $5 million in a One Month Period
By: Kevin Coy
After a pause of nearly two months, the Department of Health and Human Services Office of Civil Rights (HHS OCR) has resumed its announcement of settlements for alleged HIPAA violations, with four new settlement agreements announced between April 12 and May 10, 2017. The settlements include penalties ranging from $31,000 to $2.5 million. More >
