United states : FDA will enhance the generic for lower price

“We know that our regulatory requirements influence both the direct and indirect costs of drug development.”

If, on paper, its role is to authorize and monitor the marketing of drugs, the drug Agency (FDA) wants to go further. It has expressed its desire to encourage competition in the pharmaceutical market american better support the generic manufacturers.

Commissioned by Donald Trump, Scott Gottlieb, the head of the health and safety authority has published in the beginning of the week an article on the blog of the FDA announcing the impending arrival of measures to tackle barriers to development of the generic complex.

Some drugs are difficult to reproduce because of their “characteristics” specific. They require advanced knowledge of systems for self-injection, inhalers, for example, or in the use of peptides (chemical substance made up of amino acids that can be found for example in insulins), details the Agency of the drug.

To do this, the Agency of the drug will multiply the discussions with the generic manufacturers, and offer them precise guides to keep them abreast of the scientific procedures to be followed, in order to shorten the durations of development of the generic prior to their arrival on their market. The health products concerned by the generic complex “represent costs of increasingly important”, says the FDA.

Finally, the institution plans to fight the attempts by some laboratories to “take on rules” to prevent the arrival of copies of their best-selling medicines.

A lot of price cuts…

Increase the diffusion of generics in the United States was a campaign promise from Donald Trump to lower the prices of treatment. But will he be effective enough to achieve this goal ? The answer is yes, at least on paper.

The price of generic versions has dropped sharply overall between 2010 and 2016, according to a report commissioned by the u.s. Congress. And there is still a margin of manoeuvre for the us administration. As pointed out in this report, a few tens of generics do not have to follow the trend and have increased considerably, often due to lack of concurrent treatment. Because, if in France the price of a generic steady decline regardless of what happens, this is not necessarily the case in the United States due to a market based on supply and demand, with negotiations between the pharmaceutical companies and the payers. Thus, for the price of a copy of the drugs decrease, it must ensure that it is on the market for several years and is competed by many other generic.

… and a few hikes crazy

Among the drugs of which the patent is in the public domain, the price of the Epipen from Mylan, treatment for shock, severe allergic, rose from 100 dollars to 600 dollars between 2007 and 2016. As another example, the Daraprim, medicine for the sick of malaria and aids, for which the price has been increased to 5.000% by Turing Pharmaceutical in 2015, a laboratory, then led then by the outrageous financial Martin Shkreli.

These increases also relate to the cancer. Launched on the market several decades ago, they eventually grow more quickly than those who arrived recently, as pointed out in an article in the scientific publication, Jama Oncology, Thursday, October 6,

The generics do not get a grip even with the rising costs

The other hand, promote copies of medications may not be enough. They are already widely distributed, representing 89% of the volume of prescriptions in the United States, according to IMS Health. And the total share of the income of credits is increased from 29% in 2013 to 26% in 2016. And this, while the total expenditure on drugs in the United States, after discount, increased 5% this year, says IMS Health.

The reason is that these copies of medications do not weight the high price of new treatments and those whose patent is still protected. New anticancer drugs are part of the drug responsible for this trend. Their launch price per life year gained was multiplied by 4 in the last twenty years in the United States, says the OECD. In addition, a new class of cancer treatments, based on the engineering of the genome arrives on american soil, and fears of a new price inflation. the new treatment of Novartis against the acute lymphoblastic leukemia (all costs 475.000 dollars per patient, for example.

An increased risk of concentration in the generics sector ?

Another item that might be of concern: the sustainability of the generic activities. Using the FDA could bring a second breath in the development of some generic, but the multiplication of competitors could have a perverse effect.

Low margins induced by more copies of drugs may reduce the supply of generic with less players coming in, and promotion of movements of consolidation in the sector, as explained in the report published in the scientific journal Jama Oncology, 2016. And if the number of “génériqueurs” is reduced, and the competition between them will also be less strong. Teva is already suffering from increased competition in the copies of the medication. The big pharma has chosen to reduce the wing with the elimination of 7,000 positions in the world, and the closure of a dozen plants over the next two years.

Leave a Reply