FDA’s Covid-19 Battle a Legal Test for Industry: Author
[Review by Jim Dickinson] The global Covid-19 pandemic has brought accountability to the forefront for both the regulated industry and regulators, law book author Roseann B. Termini tells FDA Webview in a brief statement. “Compliance is critical and Congress has demanded that FDA step up enforcement of possible fraudulent coronavirus tests,” she says. With enforcement in the forefront and a wake-up call to stakeholders and the agency, Termini says her 12-volume Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Cosmetics, Veterinary and Tobacco Products, available in print, e-book that mirrors the full print and 12 subject-specific e-books, provides illustrations of actual enforcement actions across the spectrum of products the agency regulates, from Warning Letters to criminal prosecution by FDA and the U.S. Department of Justice.
Termini’s descriptions of the law are unusual in that they are expressed in plain language, avoiding legal jargon, and compare different industrial areas of agency regulation where other authors confine their explanations to industry-specific statutes and dependent FDA regulations. An example is in her 10th volume’s Chapter 6 dealing with the duty to warn and federal preemption of state court actions, where Termini contrasts the Medical Device Amendments’ explicit grant of preemptive authority with congressional failure to do the same for drugs.
This, she writes, allowed the Supreme Court in 2011 to establish different failure-to-warn standards for branded and generic prescription drugs. “Succinctly stated, federal exemption applies to generic drug products … and the opposite to brand name drug products.” This trans-industry perspective in plain language on like legal issues under different statutes should help readers with and without legal training to stay out of trouble.
Trouble with FDA has long been easy to fall into, especially in the medical device field where statutes are newer (since 1976) and the number of companies to be regulated are far greater than food and drug companies. Out of this active arena Termini has chosen the 2005 case of FDA v. Utah Medical Products to illuminate a vivid example of a federal court releasing a company from over-zealous FDA regulation. Declaring the agency guilty of “nitpicking” the company on regulatory “technicalities,” the trial judge effectively liberated an entire industry from such oppression, writing:
“Product safety is not an issue in this case. Processes and procedures are. “Validation” is the key word, and has often been noted, ‘many roads lead to Rome.’ The fact that the road chosen by Utah Medical may be different in degree than that thought to be appropriate by a regulator, does not mean that it is wrong, or in violation of the regulations. ***Without a doubt, the United States captured Utah Medical’s attention in the past, and whatever modest deviations from regulations may have occurred in times past no longer exist at present. It makes no sense for the court to order Utah Medical to do something they are already doing.”
Whether FDA will again assert itself against “technical” regulatory violations by industry might seem doubtful in the Covid-19 pandemic, but legal experts like Termini say now is not the time for complacency. Notwithstanding FDA’s 5/4 announcement that all routine inspections are suspended indefinitely, BakerHostetler attorneys are among those who say that now is the time for regulated industry to be making specific GMP adjustments. “This includes conducting internal audits of GMP compliance and increased scrutiny in specific areas that may relate to Covid-19,” the company says in an online post.
It may also be the time to prepare by ensuring that key personnel both at FDA and the regulated industry have Termini’s book and relevant volumes, now in $36 e-books, at hand.
Volume I: The “Why” of the United States Food and Drug Administration, Landmark Legislation and Court Decisions
Volume II: Food and Drug Law Administrative Primer
Volume III: Food and Drug Administration Criminal and Civil Enforcement Strategies
Volume IV: Medical Device and Radiation Emitting Products Regulation
Volume V: Human Drug Regulation– Approvals, Promotion, Marketing, Warnings, Accountability and Postmarket Surveillance
Volume VI: Biotechnology and Biologic Products Regulation
Volume VII: Veterinary Products Regulation
Volume VIII: Personal Care Products Regulation
Volume IX: Food Regulation—Food Safety, Recalls, Claims, Additives, Allergens, and Biotechnology
Volume X: Dietary Supplements, Herbs and Botanicals Regulation
Volume XI: Tobacco Products Regulation
Volume XII: Product Classification, Foreign Corrupt Practices and Globalization