“ME-TOO” DRUG REVOLUTION: A PRODUCT OF REGULATORY IMPROPRIETY

  • Dipanjan Bhattacharjee
  • Saurabh Agarwal

Abstract

Amidst all the brouhaha, often the regulatory agencies, for instance the United States Food and Drug Administration’s (US-FDA) role in bringing about what is being so cleverly termed as the ‘me-too drug revolution’, has escaped scrutiny. Bearing in mind the pre-eminent status of USFDA in regulatory world, it would be useful to examine some of their strategies that have helped facilitate this revolution. The surge seen in the approval of me-too drugs can be attributed to a regressive policy of evaluating a new drug against a placebo or using non-inferiority trials, which in turn has often allowed an easy rite of passage for the me-too drugs. So has the Prescription Drug User Fees Act (PDUFA) by allowing rapid approval of drugs. However, this has not necessarily translated into safer drugs! Further, advisory committees that are rife with conflicts of interest, a legally weakened status bestowed upon the USFDA and a no-holds barred approach adopted by the industry towards direct to consumer advertisements (DTCA), has allowed me-too drugs with dubious safety profiles to flourish in the markets. It has been suggested on many fronts that by undertaking measures, for instance an increment in the US congress appropriations to the US-FDA, vesting punitive powers in the agency to rein in the errant pharmaceutical companies as well as dealing with the conflicts of interest within the advisory committees could go a long way in preventing the undue and potentially dangerous proliferation of me-too drugs.

Keywords: PDUFA, me-too drugs, USFDA, DTCA, Advisory committees.

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How to Cite
Bhattacharjee, D., and S. Agarwal. “‘ME-TOO’ DRUG REVOLUTION: A PRODUCT OF REGULATORY IMPROPRIETY”. International Journal of Drug Regulatory Affairs, Vol. 4, no. 3, Feb. 2018, pp. 11-18, doi:10.22270/ijdra.v4i3.185.