Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life science disciplines.
Industry Insights
There’s No Reply At All: It’s Never a Good Idea to Ignore FDA During an Inspection (and, In Fact, It’s Illegal)
By: Alan G. Minsk & Robert Durkin
Rule Number One: If a facility is regulated by the Food and Drug Administration, the agency may inspect it (although there are some boundaries, not discussed here). Rule Number Two: Assuming Rule Number One applies, the facility cannot deny FDA access to those records and information to which it is entitled. In fact, it is a prohibited act. Recently, FDA issued a Warning Letter to a manufacturer of over-the-counter drug products (including hand sanitizers) reminding industry of Rules One and Two. Reading the Warning Letter reminded the author of the 1981 classic rock song by Genesis, “No Reply At All.” More >
And I Won’t Tell No One Your Name: Doesn’t Matter, FDA Reminds IVD Industry of IRB Review in Certain Cases
By: Alan G. Minsk & Laura S. Dona
The authors doubt the Food and Drug Administration was humming the Goo Goo Dolls 1995 hit, “Name,” when it drafted its letter, dated October 18, 2021, to manufacturers of in vitro diagnostics to remind them that the agency requires Institutional Review Boards to evaluate all clinical investigations of medical devices that involve human subjects, including those that use leftover, de-identified human specimens in FDA-regulated studies. FDA defines “leftover human specimens” as “remnants of specimens collected for routine clinical care or analysis that would otherwise have been discarded.” Even though, as the song lyric goes, “And I won’t tell no one your name,” to FDA, it doesn’t matter. The agency requires IRB oversight and evaluation. The agency said that this requirement includes data used to support an investigational device exemption, a medical device marketing application, or a submission to include IVD technical or analytical studies that use human specimens. More >
Recruitment Incentives in Clinical Trials
By: Neil W. Hoffman & Laura S. Dona
Recruiting a sufficient number of trial participants is a common difficulty for clinical trial sponsors. To obtain such numbers, sponsors may offer financial incentives to investigators or study sites or site personnel to identify and recruit participants. Such arrangements are not expressly precluded by the U.S. Food and Drug Administration (FDA), though it does have certain disclosure requirements that could be applicable. But drug and medical device manufacturers that sponsor clinical trials should be cognizant of potential regulatory risks inherent in such recruitment arrangements. Also, various organizations have called for more governmental regulation of recruitment incentives in clinical trials, so it is possible that we may see increased governmental enforcement in this area going forward. More >
DOJ/FTC Regulatory Update Regarding Pharmaceutical Companies
By: Jeffrey S. Jacobovitz
The Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) have both taken recent activity, which indicates there will be close scrutiny and enforcement of the pharmaceutical industry. The DOJ announced on October 1, 2021, that three generic pharmaceutical companies have agreed to pay over $447 million to resolve False Claim Liability for Price Fixing of Generic Drugs. The three companies, Taro Pharmaceuticals USA, Sandoz Inc., and Apotex Corporation resolved claims arising from a large generic price-fixing case that has involved many generic companies and is still pending. More >
Insurance Coverage for Cyberattacks?
By: Lori L. Wright & Rebecca L. Kolb
With the many recent, high-profile ransomware attacks, many companies are likely assessing their own cybersecurity and risks. Seeing the crippling effect a cyberattack can have on, for example, the nation’s largest infrastructure systems naturally brings to mind the potential impact of a similar attack on one’s own company, which likely leads to questions about available insurance coverage for such attacks. Nearly every industry faces serious risks. For example, a breach in hospitality and retail businesses could expose customers’ credit card information, a breach in education and healthcare risks exposing personal protected information, and a ransomware attack on a manufacturing plant could result in a complete shut down until a ransom is paid. More >
