How Will 'Me Too' Drug Regs Affect the Biotech Industry?

by: Pharmalot

The drug development race is pockmarked with efforts to discover and market a first-in-class treatment. Of course, not everyone can be first, which means there are likely to be other meds that become available. This has become known as the "me too" syndrome, in which one drugmaker after another tries to develop a med similar to a big seller and grab a piece of the business.

This approach, however, has been skewered for failing to yield needed innovations and using resources - at companies and at the FDA - that might be put to better use. So how can this be modified in a way that would realign priorities and generate better outcomes and returns for all considered?

An essay in the Journal of the American Medical Association suggests an alternative approach - require me-too meds to prove superiority over a placebo or non-inferiority to another drug, but only until a generic version is approved, write Joshua Gagne and Niteesh Choudhry of the department of nedicine, Brigham and Women’s Hospital and Harvard Medical School (here is the abstract).

And then what? They propose drugmakers seeking FDA approval must demonstrate, not just noninferiority, but superiority compared with available drugs. Superiority could be established by based on improved safety or efficacy; additional indications could be sought for other populations, such as the elderly or children, or a new indication may be pursued altogether.

Of course, they note that natural market forces may limit further development of me-too drugs and third-party payers can certainly impose higher co-payments. But this does not stem the use of public resources - namely, tax dollars spent by the FDA. The goal, they write, is not to limit competition, but raise the bar for approving "next-in-class" drugs, "which may help address the market distortions that patents for me-too drugs currently create."

"This proposed approach is merely a modification of existing regulatory structures to help maximize the return from the societal investment on prescription drug approval," they maintain. "If reviewing (me too) applications adds drugs to the market that are not any better than a multitude of existing products, instead those efforts should be devoted to the evaluation of other therapies that may have greater potential for making improvements in resource use, safety and efficacy."

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