FDA Looks To Remove Obstacles To Generic Competition


The Trump Administration has long talked about lowering the cost of prescription drugs. Earlier this month, the FDA announced it would be holding a public meeting on July 18th to do just that. The FDA is looking to identify ways that pharmaceutical companies are using FDA rules and regulations to prevent generic competition from coming to the market. Scott Gottlieb, the head of the FDA, has said that he wants the regulatory agency to stop pharmaceutical companies from “gaming the system” to prevent or delay the entry of generics into the market.

Gottlieb released a blog post where he expanded on the FDA’s position. “We know that sometimes our regulatory rules might be ‘gamed’ in ways that may delay generic drug approvals beyond the time frame the law intended, in order to reduce competition,” he said. “We are actively looking at ways our rules are being used and, in some cases, misused.”

Currently, the FDA does not consider price when looking at approving a new drug. But Gottlieb has said that improving access to generic competition would eventually lower costs. There are significant obstacles for generic companies looking to enter the market. Pharma companies with branded products can limit the availability of products for testing by generic companies. Branded companies can also prolong negotiations with generic firms over the implementation of shared risk-management programs. There have also been issues with branded firms using citizen’s petitions to delay generic competition.

Gottlieb has said that the FDA will be looking at potential changes to policies and programs. The changes could include greater collaboration with other agencies. Republican Senator Chuck Grassley recently urged Gottlieb in a letter to consider working with the Federal Trade Commission and the Justice Department to curb anti-competitive behavior in the drug industry. FDA law firms will likely be working on figuring out how new FDA changes will affect the industry.






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