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

• You Can’t Change That: FDA Reiterates Risk of Delegating Responsibility in Quality Agreements 
• I Won’t Back Down: Another Company Refuses to Permit FDA to Inspect 
• Here, There, and Everywhere: Opioid Manufacturers and Distributors Under a Brighter Spotlight
• Conditional Optimism or Securities Fraud? Appellate Court Affirms Dismissal of Class Action against Biopharmaceutical Company; Shows Importance of Communicating Adequate Caveats to Balance Optimistic Statements and Factual Omissions in Order to Avoid Finding of Scienter under Rule 10b-5
• These Flakes Can’t Fake it – FDA Says They’re Not Medical Foods

 Industry Insights

PHARMACEUTICALS

You Can’t Change That: FDA Reiterates Risk of Delegating Responsibility in Quality Agreements
By: Alan G. Minsk

In the span of three weeks, the Food and Drug Administration issued Warning Letters to two dietary supplement companies, in part, for relying, to their detriment, on quality agreements. We discussed another similar Warning Letter in a recent Bulletin. Regardless of the type of FDA-regulated product, the agency made clear that, despite an agreement, a company that sells a product cannot delegate its regulatory compliance responsibilities – to quote Raydio’s 1979 single, “You Can’t Change That.” More > 

I Won’t Back Down: Another Company Refuses to Permit FDA to Inspect
By: Alan G. Minsk 

Not long ago, we wrote about a company that refused to permit an FDA investigator to conduct an inspection. Well, here we go again. Apparently a fan of the late, great Tom Petty, the company told the agency, “I won’t back down.” More > 

Here, There, and Everywhere: Opioid Manufacturers and Distributors Under a Brighter Spotlight
By: Sara M. Lord and Deborah L. Livornese

In June 2017, a bipartisan group of state attorneys general announced that they were jointly investigating the marketing and sales practices of opioid manufacturers. While the group initially did not identify any targets of the investigation, it was subsequently announced that the investigation had originally “focused exclusively” on Purdue Pharma. On September 19, 2017, however, the coalition, consisting of attorneys general from forty-one states, announced that they had issued subpoenas to five opioid manufacturers, and document demands to three distributors, as part of their expanded investigation into whether any illegal conduct by the opioid manufacturers or distributors contributed to “creating or prolonging th[e] opioid epidemic.” More > 

Conditional Optimism or Securities Fraud? Appellate Court Affirms Dismissal of Class Action against Biopharmaceutical Company; Shows Importance of Communicating Adequate Caveats to Balance Optimistic Statements and Factual Omissions in Order to Avoid Finding of Scienter under Rule 10b-5
By: Joseph Alley , Jr. and Leah D. Braukman

On August 22, 2017, the United States Court of Appeals for the First Circuit (the “Court”) affirmed the dismissal of a securities fraud class action against Sarepta Therapeutics, Inc. (the “Company”), a biopharmaceutical company focused on the discovery and development of therapies for the treatment of rare neuromuscular diseases, such as Duchenne muscular dystrophy (“DMD”), and certain of its current and former officers, that asserted violations of Section 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Rule 10b-5 enacted thereunder. More >

FOOD

These Flakes Can’t Fake it – FDA Says They’re Not Medical Foods
By: Deborah L. Livornese and Kalie E. Richardson

FDA recently issued a warning letter to a medical food manufacturer for several violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The violations were discovered during FDA’s inspection of the facility. FDA said that four of the manufacturer’s products did not meet the definition of a medical food and were instead unapproved new drugs, misbranded conventional foods, and misbranded dietary supplements. More >