Recently, the US FDA issued a news announcement announcing Scott Gottlieb's policy statement on adding new review channels and promoting price competition for inadequately competitive generic drugs.
FDA has taken many measures to reduce drug prices
As we all know, the United States is one of the countries with the highest prescription volume and the lowest price for generic drugs. After years of price reductions, generic drug prices in the United States have little room to continue to fall. Relevant literature reports that the average profit level of generic pharmaceutical companies in the United States is only 5%. In order to guide the healthy development of generic pharmaceutical industry, FDA has formulated and adopted a number of policies and measures.
On the one hand, the FDA continues to increase its review and approval of generic drugs. The number of ADDA (generic drug applications) approved in 2018 is as high as 1003, which once again refreshes the historical record. On the other hand, the FDA is beginning to realize that the effect of price reduction brought by increased approval is not obvious. According to the FDA survey, 43% of newly approved generic drugs are not listed in the United States, and many brand drugs are not copied or sold by enterprises. The price of brand drugs is still high. In order to deal with these situations, FDA has taken a number of measures and put forward the idea of "global integration of generic drugs", hoping to reduce the cost of generic drug development by this way, realize the goal of "changing cages for birds", and provide more space for the price reduction of generic drugs. In addition, in order to solve the problem that some products are not copied by enterprises, the FDA has issued a list of products whose patents have expired for many years without generic drugs on the market, and opened up a new review channel to promote the development of such generic drugs.
There are many factors affecting the development and sales decision-making of generic pharmaceutical manufacturers, such as limited market potential and high technology threshold, which will affect the development interest of generic pharmaceutical enterprises. But after losing patent and exclusive period protection, if there is no anticipated generic competition, the price of brand drugs will remain high, which will directly harm the interests of patients.
Developing CGTs Channel to Encourage the Listing of Generic Pharmaceuticals
In order to solve this series of problems, FDA is also a big headache. For drugs with complex technology, prescription and drug delivery tools, the FDA has actively explored and issued a series of product-specific guidelines to guide generic drugs scientifically and technically. In addition, the FDA is taking a new approach to encourage generic drugs to enter the market by opening up a new review channel, Competitive Generic Therapies (CGTs). When generic drug competition is insufficient, generic drug applicants can apply for CGTs. The so-called inadequate competition is that in the FDA orange book, the same generic name compounds correspond to no more than one product. This channel is based on the Reauthorization Act and on the new powers conferred on FDA by the United States Congress.
Under the CGTs channel, the applicant can apply to FDA for CGTs confirmation at or before the submission of ANDA information. If the product is awarded CGTs confirmation, FDA can speed up the review of generic drugs at the request of the applicant. CGTs identified many early benefits for applicants, including product development meetings with FDA to discuss specific scientific issues and possible problems, such as developing acceptable R&D solutions and alternatives. These early benefits can reduce product review cycles and cycles, thereby reducing review time.
If awarded CGTs, the generic drug is expected to have a 180-day market exclusive period, provided that the generic drug is the first approved ANDA for such products under the CGTs channel and meets other conditions.
Since the opening of this new channel, FDA has been rapidly identifying and authorizing CGTs-eligible drugs. Up to now, the FDA has awarded more than 100 CGTs. Between August and December 2018 alone, the FDA approved five first CGTs to be marketed, and granted the corresponding 180-day market monopoly period.
The opening of CGTs review channel is of great significance. Although FDA has special review channels such as "priority review", "breakthrough therapy", "fast track" and "orphan medicine", these channels are all for innovative drugs, and CGTs are the only new special channel for generic drugs. Once generic drugs are on the CGTs channel, they can hold seminars with the FDA to discuss development strategies that were previously available to innovative drugs. In addition, CGTs offer preferences such as accelerated approval, market monopoly period, etc. For generic drugs, this treatment can only be enjoyed if they win a patent challenge or reach a settlement.