FDA weighs in to improve generic competition
pharmafile | June 27, 2017 | News story | Medical Communications, Sales and Marketing | FDA, generic drugs, pricing debate
Since Scott Gottlieb was appointed Commissioner, the FDA has been on a marked push to tackle two areas: drug pricing and the opioid crisis. Only last week, Gottlieb released a blog post on the FDA website where he criticised those ‘gaming’ the regulatory system to stall generic competition’s entry onto the market.
In further steps to improve the speed with which generic drugs can reach the market, the FDA announced that it had published a list of off-patent, off-exclusivity branded drugs without approved generics and had also enacted a new policy to expedite the review of generic drug applications in areas where competition is narrow.
It is hoped that the two changes will dovetail to speed up the approval process for generic competitors; the list of branded drugs that have no listed patents or exclusivities will ensure that companies could potentially pick out targets and have its ANDA expedited through the process due to the new changes.
The FDA revealed that these were the first actions taken under the Drug Competition Action Plan that was announced at the end of the previous month. It is an interesting signal in the step-change that has been brought about by the change of Commissioner, not least in the speed by which new changes and announcements are being made.
Some criticism that has been levied already against the changes that have been brought forward so far is that generic pricing does not make up a large portion of the overall cost of pharmaceutical products. It has been noted that orphan and oncology drugs are the areas where prices have been escalating rapidly – highlighted by the recent example of Marathon’s attempts to raise a Duchenne Muscular Dystrophy treatment’s cost to $89,000.
It should be said that the FDA’s remit does not strictly involve pricing of drugs and the most it can be expected to do is to develop regulatory steps to improve competition.
“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” said FDA Commissioner Scott Gottlieb. “Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”
Gottlieb further commented that the agency is keen to pursue further actions to tackle drug pricing, raising the interest about how far the body can go to actively attempt to reduce prices. The industry will be watching the agency keenly after a rollicking start to Gottlieb month and a half in the role.
Ben Hargreaves
Related Content
GSK’s Jemperli accepted for FDA review for endometrial cancer treatment
GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental …
FDA approves ImmunityBio’s Anktiva bladder cancer treatment
ImmunityBio has announced that the US Food and Drug Administration (FDA) has approved Anktiva (N-803, …
Roche’s Alecensa approved by FDA as lung cancer treatment
Roche has announced that the US Food and Drug Administration (FDA) has approved Alecensa (alectinib) …
