As part of the new Drug Competition Act Plan, the FDA aims to make important changes which would improve competition in the pharmaceutical market and facilitate entry of lower-cost alternatives. These actions are among the first taken under the agency’s Drug Competition Action Plan, announced by FDA Commissioner Scott Gottlieb in late May.
“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.”
Drug Competition Action Plan
In order to proper the Drug Competition Action Plan forward, the agency has published a list of off-patent, off-exclusivity branded drugs without approved generics and implemented a new policy to expedite the review of generic drug applications where competition is limited.
The goal of these moves is to promote new generic drug developments and allow for easier consumer access towards more affordable medication. By posting the list of drugs that have no listed patents or exclusivities and any approved generics, the agency hopes to encourage the development of new generic drugs.
Moreover, the agency has reaffirmed its support for the development of new generic drugs via plans to expedite the review of generic drug applications to ensure that these new drugs will be available in the market as soon as possible.
Despite the sped up process, the agency still intends to maintain its present degree of transparency so as to not compromise the presence of market competition, which the agency believes has the potential to be beneficial to patients.
Other changes to the existing policy include increasing the number of reviews for generic drug applications. The agency plans to expedite the review of generic drug applications until there are three approved generic available in the market for any given drug.
Conceptually, having more generics within the drug market would drive prices down thus, allowing consumers to better access of multiple FDA-approved generics.
“I am committed to continuing to pursue additional policy steps, under the FDA’s current authority, to help reduce the burden on patients who have a difficult time paying for the medicines they need,” continued Commissioner Gottlieb.
Pros and cons
On the surface, the Drug Competition Action Plan certainly has many benefits namely increasing competition and reducing drug prices. By expediting the review application for generics, patients will have quicker and greater access to medications without having to rely on expensive branded drugs. In fact, for many especially those with limited healthcare insurance, these drugs may not even be attainable without the presence of a generic equivalent as the branded versions cost too much.
Meanwhile, the introduction of new generics into the market should act as an impetus for pharmaceutical companies to develop new drugs and strategies towards the distribution and promotion of their drugs. At the end of the day, the consumer stands to benefit the most with minimal intervention from both public and private interest.
But, will that indeed be the case? In fact, for many, the Drug Competition Action Plan is seen as nothing more than a plan to deregulate and loosen FDA restrictions on the drug market.
For much of the healthcare sector, the FDA has always been considered the last bastion of regulation before a drug is considered to be completely safe for consumer use. As such, there are hundreds of tests, thousands of hours and millions of dollars spent to approve these drugs.
Even then, the system is not perfect with past cases of drugs being pulled off the market despite initial FDA approval. Now, with the process sped up significantly, the risk of dangerous and possible lethal drugs making it into the market becomes one that is almost too real.
Most importantly, these are just the first few steps that the “new” FDA is taking towards making generics more accessible to the general public as well as loosening FDA restriction.
All of these come under the new Trump Administration which aims to find ways to lower the cost of prescription drugs. The FDA has plans to reveal additional aspects of the Drug Competition Action Plan in the near future together with holding a public meeting to discuss the plan on 18 July. MIMS
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