May 24, 2024

The Federal Commerce Fee, with the help of the Meals and Drug Administration, is warning prescription drugs to not unfairly attempt to block generic drug makers.

In keeping with the FTC, some prescription drugs “improperly checklist patents within the FDA’s catalog of ‘Accepted Drug Merchandise with Therapeutic Equivalence Evaluations,” generally referred to as the ‘Orange E book.’” Such conduct unfairly prevents different corporations from coming into the market with off-brand alternate options at a less expensive worth.

“Improper patent listings within the Orange E book illegitimately delay or lock out generic producers from coming into the market, depriving People of entry to lower-cost medicines and drug merchandise,” stated FTC Chair Lina M. Khan. “The FTC is making clear that improper Orange E book listings could also be an unfair technique of competitors in violation of the FTC Act. We received’t hesitate to make use of all our instruments to fight unlawful practices which might be inflating the worth of well being care, together with medicines.”

“The FDA appreciates and helps the FTC’s efforts to look at whether or not model drug corporations are impeding generic drug competitors by improperly itemizing patents within the Orange E book,” stated FDA Commissioner Robert M. Califf, M.D. “The FDA stands prepared to help the FTC as a part of our lengthy historical past of collaboration to guard American customers, together with our continued engagement below the Govt Order on Competitors within the American Financial system to assist determine and tackle efforts to dam or delay generic drug and biosimilar competitors.”