FDA helps generic manufacturers to obtain original research drugs as research and development reference

Source: DXY 2014-12-8 in some cases, the original research drug company refused to sell the brand drugs to the prospective generic applicants as the listed reference preparation, and the FDA's guidance is to help the prospective generic applicants obtain these drugs Prospective generic applicants need to conduct bioequivalence (be) and other tests for their generic drugs The problem of generic companies not being able to access listed reference drugs may arise, which are not available through regular distribution channels because they are restricted by distribution (either through risk assessment and mitigation strategies (REMS) or through retailer owners' willingness) As some brand drug companies argue that providing sufficient listed reference drugs to prospective generic drug applicants would violate their REMs, FDA has developed a procedure to provide assurance to brand drug companies FDA has reviewed the bioequivalence research programs of generic drug companies and determined that they contain safety consistent with those drugs in REMS The guidance describes how generic applicants can obtain a letter containing a statement of FDA determination that the bioequivalence study program of prospective generic applicants includes the same safety protection as those used in REMS for listed reference drugs FDA believes that it is not an illegal act to provide enough reference drugs to prospective generic applicants through REMS or to allow generic companies to conduct necessary tests on reference drugs to support their generic drugs FDA welcomes comments from the public and stakeholders on this guidance within 60 days, and consultation will begin on December 5, 2015.