Os marcos elencados apresentam os passos que levam a criacao do Orphan Drug Act
. Tanto nos EUA quanto na UE a sequencia de acoes e a mesma: criacao de uma entidade "guarda-chuva" para Distrofia Muscular (MDA-EUA e AFMFranca), sensibilizacao da rede de contatos para acesso aos meios de comunicacao social e realizacao de campanhas para recepcao de donativos (Principalmente financeiros.
is statutorily defined under the orphan Drug Act
as "a disease or
She said both NORD and the Orphan Drug Act
were created as a result of a recognition in the 1970s that drug companies were unwilling to finance research into treatments for disorders that were not prevalent.
To counter that disincentive, the Orphan Drug Act
was enacted in an effort to reduce drug loss in the area of rare diseases - "rare" defined as fewer than 200,000 cases in the United States at the time of certification.
And I know that the legal formula is going to work, based on the history of a piece of legislation called the Orphan Drug Act
. Orphan disease is a rare disease nobody was researching because the research cost far more than any potential income from the drug.
Orphan Drug Act
of 1983 and a similar proposal from the European Commission (currently under legislative approval) provide financial and practical incentives for the research and development of drugs to treat rare diseases.
Medical foods, which were designated by a 1988 amendment to the Orphan Drug Act
of 1983, are defined as "any food which is formulated to be consumed or administered enterally (i.e., either orally or through a tube) under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." Recent launches into the medical foods category include Zbar (Baker Norton), a long-acting carbohydrate snack bar that deters hypoglycemia in diabetes patients, and Cardia Salt Alternative (Applied Microbiology), a salt substitute that can also lower blood pressure.
Under the terms of the agreement, Bristol-Myers Squibb asked the UFDA to approve Taxol for the treatment of ovarian cancer, anticipating that the firm would receive exclusive marketing protection under the Federal Government's poorly drafted and much-abused Orphan Drug Act
. When this law was enacted a decade ago, its purpose was to promote the development of drugs for rare diseases.
It has been a strategy of pharmaceutical and biotechnology firms to have their compounds designated as orphan drugs under the provisions of the 1983 Orphan Drug Act
, which provide government credit for R&D expenses for an orphan drug and marketing exclusivity for seven years.
The analyst tells investors that he thinks establishing a precedent that finds Ruzurgi's approval acceptable could nullify many of the incentives in the orphan drug act
to develop drugs for orphan indications with unmet need.
The US FDA Orphan Drug Act
(ODA) reportedly provides for granting special status to a drug or biological product to treat a rare disease that affect fewer than 200,000 people in the US.
In the United States, these policies took the form of the Orphan Drug Act
(ODA), which provides both research and development tax credits, and allows extended periods of market exclusivity for firms developing products aimed at conditions afflicting fewer than 200,000 patients.