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.
May be this Professor has no clue of reality. Sometimes to become known and famous one has to rely ob “fake news”.
Mr. Thakur, I read your criticism with interest. I see that you have made a valid point right at the beginning. But, I do wish to point out that Section 708 of FDASIA also merely confers “extra-territorial jurisdiction” to the US FDA which eventually is not a balance but remains a regulatory overreach. And yes, I fully appreciate the detail of the CFR and the depth of Form 483. Nevertheless, there is a very high degree of subjectivity involved in making determinations there.
Mr. Thakur, I appreciated your criticism very much although I would have thought that in your place, I would have done this without getting this personal. But, if you feel that demeaning me personally and academics generally is the only way to project the depth of your substance, I understand.
And, Mr. Malhotra, it would be a privilege to meet you. I have to say that you read me like a book in relying on from Mr. Thakur’s criticism of one article I wrote in a newspaper!
Gentlemen, it is easy to disagree but I realize that disagreeing agreeably is a lot harder even for accomplished people. Nevertheless, there are some valid points in Mr Thakur’s note and I can take them into consideration.
Respectfully to both of you gentlemen
Srividhya Ragavan
Prof. Ragavan,
Please accept my apology. My intention was not to make it personal in any shape or form. Upon reflection, it appears I have inadvertently done so. All I wanted to do was to point out that facts contradict your opinions as expressed in your piece.
Dinesh Thakur
Thanks to both Mr. Thakur and Mr. Malhotra. I had the occasion to speak with Mr Thakur and acknowledge and apologize for my factual error. I do want to take the opportunity to note that I fully agree that we ABSOLUTELY want Indian companies to improve their quality and conform to global standards. The easiest way to become a global player is definitely by doing that.
On the subjectivity, I felt that even though the regulations are clear, there is still some level of discretion and scope of subjectivity for FDA inspectors. That said, this is infact a debatable point. Personally, I have felt that there should be global standards (and the CGMP can well become that) and there should be global inspectors inspecting all manufacturing facilities as opposed to American inspectors. But, I do see that it would involve cost and effort and have all the trappings that the WTO suffers from.
That said, I do look forward to get the opportunity to meet and/or to work with one or both of you in our efforts to make drugs safe and accessible to people.
I am indeed happy to have the opportunity to get to know both of you. Thank you.
Warm Regards,
Sri
Ms. Ragavan:
On the issue of subjectivity, wearing my manufacturing, process development and management hats, I would disagree with you. When specifications are set there is no ambiguity of what the process will produce.
Global standards should be there but every country and their bureaucrats will fight such standards tooth and nail as they will loose their power of control. ICH (International Conference on Harmonization) has been at it and what a neurotic nightmare. It takes them ages to agree to any sensible verbiage. In the mean time people die. However, global standardization is the easiest thing. [https://pharmachemicalscoatings.blogspot.com/2017/01/can-uniform-safety-health-and-effluent.html]
Going forward in the next five years I just don’t see pioneers, who brought India to be the generic supplier, will be gone. There are no replacements and visionaries. At least I have not seen any. The current “C Suite” occupiers are YES people. Their boats will be going in every possible direction.
As they say “GOD have mercy”.
Today I finished reading the book Bottle of Lies and I would like to thank you profusely for all that you have tried to make drugs safe. I take two generic blood pressure meds manufactured in India. I feel like I am choosing between stroke (not taking them) or cancer (taking them). Thank you again for bringing this information to light.
You really make it appear really easy along with your presentation however I to find this
matter to be actually something which I feel I might by no means understand.
It kind of feels too complex and extremely vast for me.
I am taking a look ahead for your next put up, I will try to get the hold
of it!