Drug Manufacturers and the Threat of Me Too Drug Makers

Patent Exclusivity

I would propose modifying the development and/or regulatory review processes to help reverse the trend towards "me too" drugs by overhauling the system that allows for drug companies to "chemically rejigger an oldie but goodie, craft a new name, mount a massive advertising campaign and sell the retread as the latest innovative breakthrough" (Mattina, 2015). The overhaul would require companies to show how their new "innovation" is different from a previous drug and what makes it more beneficial. These re-inventions of the wheel allow companies to skate past competitors who heavily invest in actually innovative drug developments by reaping the spoils of their labor after simply altering a chemical or two and claiming the innovation for themselves. In order to level the playing field and make it more of a fair practice for every company, there needs to be a system of reporting that validates and justifies the changes made to a formula before the company can proceed to market. This will eliminate the entire sector for "me too" drugs. If companies cannot show how they are bettering a formula (as opposed to simply making it different), then the review board will have no choice but to reject its application. This will encourage actual innovation rather than just the piggy-backing practices of the "me too" industry.

As DiMasi, Hansen and Grabowski (2003) show, the price of innovation is the actual issue in today's drug market. Costs are soaring and that is reflected in the price of pharmaceuticals on the market. Thus, in order to optimize the period of a developer's patent exclusivity without compromising public health and safety, I would suggest that the review board disallow competitors from essentially "stealing" the innovative formula of the company's success and barring "me too" drugs from hitting the market until the time in which the patent is in its last 5 years. Some might argue that this is manipulation of a free market system and that it will lead to monopolies and higher prices, but if a company is invested in a product it has a right to reap the rewards of its hard work and not see them despoiled by others who simply sit back and wait to steal the formula for their own profits.

Concerns about health and safety may be an issue for some consumers, however; and therefore regulations should also be geared towards optimizing the innovation and testing of these drugs to make sure that they are efficient. A company that can show that a specific drug is or is not doing what it should, through experimentation and review, will be given priority-status. This would be viewed as being health and safety-conscious by the regulatory board.