FDA takes basic steps to improve the acquisition of brand drug samples by generic companies

Source: Scott Gottlieb, director of FDA of synlin 2017-11-10, has been focusing on FDA's efforts to curb the abuse risk assessment and mitigation strategy (REMS) system of brand companies to block the entry of generic drugs In a statement on November 8, the FDA announced that the FDA has released the draft guidelines for the submission and use of drug master files (DMF) for the shared system REMS (click the link at the end of the article to read the original, and log in to see the draft guidelines) Gottlieb also stressed in the statement that the FDA is seeking new measures to reduce the possibility of brand drug companies using REMS to slow down the entry of generic competition Specifically, he said the FDA is considering allowing generic applicants to request exemption from the requirement to share REMS with innovative drug companies The draft guidance recommends how applicants submit to FDA common documents representing all participating enterprises "I hope that the use of standardized information collection processes in the new REMS document template will help simplify the drafting and review of the shared system, making it easier for enterprises to participate in the shared REMs," Gottlieb said Today's actions are the fundamental steps that we may take to implement reform in the near future " The announcement coincided with Gottlieb's attendance at the FTC Seminar on competition in the prescription drug market, at which he reiterated his concern that branded drug companies would "exploit the system's loopholes" by using rules or loopholes to delay generic approval He cited examples of brand drug companies using REMS to prevent generic companies from obtaining brand drug preparations for bioequivalence research In a statement on REMs, Gottlieb, bypassing shared REMs, said that FDA would provide information on how and when generic applicants can request exemption from using shared REMS with innovative drug companies and FDA considerations At present, the law requires brand and generic companies to reach an agreement on the implementation of a single and shared REMs, and any generic application referring to a brand drug with etasu (etasu) REMS must use a single and shared REMS with innovative drug companies, unless FDA exempts this requirement Gottlieb said the FDA is aware that an agreement on a shared system, REMs, could take a long time and prevent the timely entry of generic competitors "This exemption allows generic competitors to remain unaffected by the requirement to reach an agreement with branded drug companies on a shared system, REMs," he said This avoids the ability of brand drug applicants to use these negotiations as a way to slow down the entry of generic drugs " Gottlieb had previously testified in a congressional hearing about the possibility of allowing generics to develop their own REMS Working with other agencies since leading the FDA in May, Gottlieb has focused on promoting stronger generic competition He has repeatedly criticized branded drug companies for blocking access to generic drugs, including the use of REMS to prevent generic companies from buying branded drugs for bioequivalence research The issue was discussed at a public meeting in July to ensure that the hatch Waxman act continues to balance drug access and innovation [progress of FDA hatch Waxman public meeting and drug competition action plan - I 2017 / 07 / 19] Gottlieb talked about this topic again at the speech of National Press Club on November 3 He pointed out that generic companies usually need 2000 to 5000 doses of brand drugs to carry out bioequivalence studies comparing generic drugs with brand drugs Many generic companies told FDA that they could not obtain drugs to carry out these studies to submit applications "We often see branded pharmaceutical companies selling drugs through a strict supply chain They may have strict control over whom to sell drugs through a single professional pharmacy I think they have regulations that make it difficult for pharmacies, distributors or other people who have access to drugs to sell to generic companies, or to sell to generic companies in bulk " Gottlieb pointed out that the behavior of brand drug companies is not always under the jurisdiction of FDA, and he is willing to find ways to cooperate with other agencies to solve this problem Gottlieb also noted that the FDA is already discussing the potential for generic companies to buy branded drugs in Europe When asked about this idea by AAM, chip Davis Jr., President and CEO of AAM, said that the best option, and one way that AAM supports, is for Congress to pass legislation such as the creations act "If no legislation has been passed, using non-U.S reference products as samples for bioequivalence testing may also be an option if FDA believes that it can rely on such products and proves that such products are the same as reference products," Davis said In short, a large number of different stakeholders have realized that the current system game needs to be corrected So the FDA and the government should use all the tools they can " If generic companies obtain authorization from FDA for covered products, and brand drug companies fail to provide "enough" REMS covered products, the create and rebuild fair access to equivalent samples Act (s.974) will allow generic sponsors to sue innovative drug companies.