A study commissioned by the Generic Pharmaceutical Assn. (Washington, DC) asserts that restricted access to drug samples from brand owners is preventing its members from filing appropriate documentation for ANDAs (Abbreviated New Drug Applications, the normal approval process for generic products). That tactic, in turn, delays or prevents generic introductions. For some 40 products (not named in the study) where restricted access has occurred, the study estimates that the delays are costing drug payers (governments, private insurance and patients) $5.4 billion annually. Further, hypothesizing that when a process for approving biosimilars is cleared at FDA, the practice will cost payers $146 million for every $1 billion in bilogics sales.
REMS (Risk Evaluation and Mitigation Strategies) is a post-approval requirement by FDA for manufacturers to carry out additional work when drugs are dispensed: patient or physician education; monitoring of side effects; and, in the most restrictive applications, authorizations for distributors, physicians and pharmacists before the drug is dispensed. “REMS is supposed to be about patient safety, and GPhA has no problem with that intent,” said Christine Simmon, SVP of policy at the association. “But brand owners are using the REMS program to prevent our members’ access to samples,” and that is a “smokescreen” for preventing generic approvals.
Typically, a generics manufacturer needs to provide bioequivalence and related data to FDA during the ANDA process. And while it is hypothetically possible to get drug samples through a back door, apparently FDA requires a documented paper trail from the drug manufacturer to the generics manufacturer.
The study, available here, was performed for GPhA by Matrix Global Advisors, a consulting firm. GPhA has tried in past Congressional legislative efforts to prevent the REMS restrictions from being used this way; but no final legislation has been voted in.