September 2018
Why don’t we have any products registered and available in the US?
Because of anti-competitive strategies used by some brand manufacturers to prevent generic developers from accessing their drugs to conduct the tests that are legally required for a generic drug to be brought to market, thereby limiting opportunities for competition that could place downward pressure on drug prices.
This gaming tactic has been recently criticized by the U.S. Department of Health & Human Services (HHS) and also by the U.S. Food and Drug Administration:
“Some manufacturers may be gaming distribution limitations to prevent generic developers from accessing their drugs.”
U.S. Department of Health & Human Services (HHS) American Patients First.
The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs May 2018, p. 27
“At times, certain “gaming” tactics have been used to delay generic competition. One example of such gaming is when potential generic applicants are prevented from obtaining samples of certain brand products necessary to support approval of a generic drug. The inability of generic companies to purchase the samples they need slows down, or entirely impedes, the generic drug development process – leading to delays in bringing affordable generic alternatives to patients in need.”
IN CANADA
Health Canada has approved MDK-Nitisinone medication for the treatment of hereditary tyrosinemia type 1 in 2016.
IN THE EUROPEAN UNION
European Medicines Agency (EMA) has approved Nitisinone MDK medication for the treatment of hereditary tyrosinemia type 1 in 2017.
