Allegations of widespread fraud concerning generic drugs manufactured overseas, especially in India, were recently highlighted in the U.S. Much focus was on the contamination found in one drug made by Ranbaxy. I do not wish to support Ranbaxy’s deplorable behaviour. Nor do I wish to belittle the importance of the ongoing efforts to fix India’s drug regulatory framework. The point here is that this focus has been deployed to undermine foreign generics.
For instance, the Ranbaxy saga unfolded 14 years ago. Since then, several pharmaceutical companies, both foreign and local, generic and innovative, have been implicated in similar or worse behaviour. Notable examples include those of Martin Shkreli’s Turing Pharmaceuticals, which hiked the price of a drug to 5,000%, and Purdue Pharmaceuticals, a company currently implicated for causing the opioid crisis. The strategy of raising fears of ‘contaminated’ foreign generics has successfully prejudiced Americans against valid generic drugs, even though they have remained a viable option.
This frenzy about contamination of drugs is due partly to the expansion of the Food Safety Modernization Act (FSMA) to include global inspections. One objective in thus empowering the Food and Drug Administration (FDA) was to work with regulators of foreign countries and create a universal Current Good Manufacturing Practice (CGMP) system for drugs.
FDA’s regulatory overreach
Instead, the FDA has positioned itself as a ‘global regulator’. For example, in a recent statement, it mentioned that it inspects all brand-name and generic manufacturing facilities around the world based on information from whistleblowers or out of concern for drug safety. Arguably, this amounts to regulatory overreach as there is no international instrument standardising American CGMP practices as the global standard.
Further, under the FSMA, if a foreign facility refuses inspection, the FDA’s power is limited to refusing the food/drug entry into the U.S. America’s interest in good manufacturing practices to protect its citizens is commendable. Nevertheless, given Washington’s current zeal to propel exports, if India or China pass legislation to inspect U.S. food or drug manufacturing facilities, U.S. companies may not readily welcome the move.
A prejudiced dialogue
In 2018, out of the 4,676 human pharmaceutical sites inspections that the FDA conducted worldwide, 61% were of foreign-based facilities. Similarly, out of 1,365 human drug CGMP surveillance inspections conducted, 55% were conducted at facilities outside the U.S. The FDA’s publicising of its ‘global vigilante experience’ paints a picture of foreign-manufactured drugs as ‘defective’ or ‘contaminated’ while not fully acknowledging some of the regulatory failures within America. To provide a perspective, the ‘drug recall list’, a list of drugs deemed defective in spite of having cleared FDA regulatory approvals for the last 14 years, runs into over 149 pages. I cite this to merely highlight that a prejudiced dialogue that does not capture all perspectives can create imprecise impressions.
As such, when the FDA inspects production facilities, there are both smaller and bigger issues that will come up. There is no scale to determine whether the problems portrayed in the final report are simple ones, such as one tap not working, or more impactful ones, such as use of contaminated water. 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.
In addition, in the U.S., there is no proper legal definition of the oft-used term ‘contaminated drugs’. Section 351 of Title 21 of the U.S. Code defines ‘adulterated drugs’ and when a drug is deemed ‘adulterated’ for being contaminated, the regulator needs to specify whether the adulteration relates to the manner of preparation, the packaging standards or the manufacturing practices.
For India, the discussion in the U.S. is notable not only because it houses generic manufacturing facilities but also because India is a nation on the verge of breaking into the innovation market. Thus, it is time India took a more robust role to ensure public availability of facts on both the importance of generics and their limitations. The country needs to create strong voices and partnerships that can highlight the benefits and pitfalls alike to create a robust space for innovation that can coexist with access to medication. After all, innovation and policy failings need not be an excuse to deny access to lifesaving medication to productive workforces.
Srividhya Ragavan serves as a Professor of Law at Texas A&M University School of Law
Published - July 09, 2019 12:05 am IST
