FDA’s Gottlieb draws those ‘gaming’ system into pricing debate
pharmafile | June 22, 2017 | News story | Medical Communications, Sales and Marketing | Drug pricing, FDA, Trump
President Trump spoke often of how pharmaceutical companies were ‘getting away with murder’, in regards to drug pricing, and now the FDA has hinted how it may seek to influence pricing, despite its limited protocol.
In reality, the FDA does not have a direct say on drug pricing – its role is to ensure that the drugs reaching the public are safe for use. However, Gottlieb, in a recent blog post of the FDA website, identified that certain companies had used regulatory rules to keep competitors from the market.
In one concrete example provided in the post, Gottlieb stated: “To perform the studies required to develop a generic alternative to a branded drug, a generic sponsor generally needs 1,500 to 3,000 doses of the originator drug. I understand that generic sponsors are willing to buy these products at fair market value; but, in some cases, branded companies may be using regulatory strategies or commercial techniques to deliberately try to block a generic company from getting access to testing samples.”
This is an example of what Gottlieb references as ‘gaming’ the regulatory system, and results in slowing the process of developing a generic competitor to a branded product. It has been noted that the real heart of the cost issue is in other areas that do not involve around older, off-patent drugs but the FDA is limited in what it can achieve with its current remit. A means of speeding up generic production would be a welcome smaller change that could be made.
Gottlieb took the opportunity of the blog post to publicise that the FDA will be holding a public meeting on 18 July to determine whether there were other such instances where the Agency could prevent other examples of regulatory ‘gaming’.
Ben Hargreaves
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