The Hindu published an opinion piece a few days back titled “Taking a myopic view of foreign made generic drugs” by Srividhya Raghavan, Professor of Law at Texas A&M University on July 9, 2019. Sadly, opinion pieces these days seem to go the same way as reported news is, void of any fact-checks and balance in views expressed.

Let me begin by highlighting “factual” mistakes in this piece. The author says “Much of the focus was on contamination found in one drug made by Ranbaxy”. This one sentence states three facts incorrectly.

A cursory review of the settlement agreement prior to authoring this piece would have revealed that the company pled guilty to knowingly introducing “adulterated” drugs (not contaminated drugs, a term which is used to obfuscate the issue) into US interstate commerce with an intent to defraud or mislead. Second the plea agreement lists the following drugs: Sotret, Gabapentin, Cefaclor, Cefadroxil, Amoxycillin & Amoxycillin and Potassium Clavunate. By my math, these are more than one drug. In fact, the US FDA had invoked its seldom used Application Integrity Policy to block the importation of as many as 30 drugs made by this company into the US. Third, the focus was not on something that was “found” in any drug made by Ranbaxy, it was on compliance with the US cGMP requirements for product quality. This is just one simple illustration of how statements not based on facts are used to advance a self-serving narrative.

Then there is the usual whataboutery to distract attention from the real issue. The author says “Ranbaxy saga unfolded 14 years ago” and that “strategy of raising fears of “contaminated” foreign generics has successfully prejudiced Americans against valid generic drugs”. One only need to look at the most recent US FDA annual report from the Office of Compliance to see that more than a third of the Warning Letters issued in FY 2018 for cGMP violations are for data integrity. One wonders how the author’s lack of support for Ranbaxy’s behavior comports with her views of the same exact behavior documented by many generic manufacturers who make their product overseas documented extensively by the US regulator last year? Last year was not 14 years ago. And is it fair to ask if finding carcinogens in your blood pressure medication that has been documented extensively now with generic Valsartan real? Or is this called fear-mongering? How about the Canadian Genric Drug Maker Apotex withdrawing 31 ANDA approvals from the US FDA because it couldn’t substantiate data (which was at the core of the case against Ranbaxy) filed from its facilities in Bangalore & Mumbai yesterday (July 10, 2019). Is that recent enough?

Drawing comparison to the abhorrent behavior at Turing Pharmaceuticals of raising prices to making substandard drugs and selling them to unsuspecting patients does a real disservice to any cogent argument that can be made in favor of using good quality generic drugs. She argues that somehow what the US FDA does with inspecting foreign facilities is an “over-reach” of its jurisdiction and that the observations made by the US FDA inspectors on Form 483 are against what she calls “American cGMP practices as the global standard”.

What she does not mention is that Section 708 of FDASIA explicitly confers this extra-territorial jurisdiction to the US FDA for enforcement. How’s that for a balanced view?

I wish the author would take a few minutes to review any of the inspection observations (Form 483) from any time she chooses and highlight one instance where an observations made by an inspector is not under a specific section of Code for Federal Regulations (CFR). This is absolute nonsense directed toward those who do not understand how the regulations work; and surely not expected from a legal professional.

The author further argues that “there is no scale to determine whether problems portrayed in the final report” and that “the absence of a proper scale provides a loophole, enabling the regulator to cherry-pick and treat all instances of non-compliance as egregious violations”. Again, a few cursory minutes spent on the Google machine would have explained in reasonable detail the difference between observations on Form 483, a Warning Letter, An Import Alert, an invocation of the Application Integrity Policy and a Consent Decree. This argument is specious at best and misleading at worst and tells you what the agenda behind the comment is.

Academics are expected to advance opinions based on facts and professors of law are expected to understand statutes before opining on their application. As demonstrated above, this opinion piece fails miserably on both counts.