The FDA is clarifying its generic drug approval process in an effort to encourage market competition.
Toxoplasmosis damages the brain, eyes and other organs, but the going price for treatment is $750 per pill. However, the cost of this drug may soon drop as the United States Food and Drug Administration (FDA) has approved the first generic version of the drug, thanks to the new Drug Competition Action Plan (DCAP) of the United States. agency.
The FDA has credited DCAP for encouraging drugmakers to develop generic versions of brand name drugs. The plan was designed to create market competition and reduce drug costs. But the pharmaceutical industry needed additional guidance to navigate the generic drug approval process.
In an effort to clarify DCAP and generic approval pathways, the FDA released an industry guidance last month. The guidance detailed incentives for drugmakers to develop generic versions of drugs without market competition. The agency also updated its list of brand name drugs that are not protected by patent and do not face competition. The FDA explained that these efforts were aimed at increasing the agency’s transparency and making the generic drug approval process more efficient.
These recent agency guidelines come three years after the FDA announced an earlier action plan and Congress amended the federal Food, Drug and Cosmetic Act to create a new generic approval pathway. . Since this amendment in 2017, the FDA has continually provided updated resources with the goal of encouraging the approval of cheaper generic drugs.
The agency said its goal is to “remove barriers to generic drug development and market entry with the goal of stimulating competition so consumers can get the drugs they need at affordable prices.” affordable”.
Recently released guidelines have clarified the agency’s generic approval process. According to the guidelines, a generic drug applicant can now apply to be designated as a Competitive Generic Therapy (CGT). The FDA will label a drug as CGT when the only competitor in the market is the brand name drug and the brand name version does not have a pending patent.
Once a drug has been labeled as CGT, the product will receive 180 days of market exclusivity. During this six-month period, the FDA cannot approve another form of the same drug. This market exclusivity gives the drug manufacturer time to take advantage of the treatment without any competing generic products on the market.
The FDA also has the discretion to expedite the development and review of a product designated as CGT. If the agency expedites the process, the FDA can participate in the drugmaker’s product development and pre-submission meetings. These meetings give drugmakers the opportunity to discuss their concerns and explain the contents of their drug applications to the agency before submitting them for formal review. The FDA has suggested accelerated development could help a manufacturer get its drug to market faster than it otherwise could through the traditional approval process.
In its guidelines, the FDA explained that market exclusivity and expedited review were created to encourage manufacturers to invest in generic therapies. The agency recognizes that drugmakers may not be interested in developing generic forms of drugs that treat small patient populations or are complex and time-consuming to create. Even though some generic drugs are not very profitable for the manufacturers, the public needs these generic products. The FDA explained that more generics will ensure patients have better access to their drugs at affordable prices.
In an FDA report released in December, the agency found that drug prices continued to fall as more generics entered the market. When there was a brand name and a generic version on the market, the manufacturer’s price of the generic version was on average 39% lower than the manufacturer’s price of the brand name drug. The average generic manufacturer price continued to decline with more generic versions of the drug available on the market, according to the FDA report.
To help drugmakers determine what types of generic drugs to develop, the FDA also updated its list of brand name drugs that no longer have market exclusivity or patent protection and do not have competition. generic. The list of drugs currently unprotected from generic competition is nearly ten pages long. The FDA wanted this list to “enhance transparency” and encourage the development of generic forms of drugs that have no market competition.
Although the FDA has supported generic competition, researchers have questioned whether the quality of generic drugs is always equivalent to the quality of the branded version. For example, a 2017 study looked at blood pressure medications and found that patients who took the generic drugs experienced more side effects than those who took the brand name version. The authors of this study suggested that generic drug manufacturers need greater oversight to ensure adequate quality control.
Niteesh Choudhry, a physician and professor at Harvard Medical School, reviewed the study and suggested that differences in inactive ingredients may cause some patients to experience side effects after taking generics that they may not experience when taken. they take the brand name drug.
Although there may be slight differences in chemical compositions between generic drugs and brand name drugs, Choudhry always recommends that patients try generic drugs first, as the high cost of brand name drugs can cause patients to skip doses. It recognizes that to control drug spending and keep drugs affordable to the general public, generic drugs must be available.
Even though researchers have questioned the level of efficacy of some generic therapies, the FDA has argued that increasing drug competition through generic development is a “top priority” for the agency and the US Department. Health and Human Services (HHS).
Alex Azar, the secretary of HHS, acknowledged that generic competitors drive down drug prices. He praised the FDA’s efforts to review generic treatments, saying “the most obvious element of a more competitive pharmaceutical market is simply more options for patients, especially generic options.”