Who's Winning NTI Substitition War-Brands or Generics?
Epstein, Debbie, Drug Topics
In the battle over generic substitution for narrow therapeutic index (NTI) drugs, only one state has adopted regulations against NTI substitution, despite efforts by the branded industry in dozens of states.
"The issue came to a head this year because of our pending launch of warfarin sodium," said Charles M. Mayr, director of corporate communications for Barr Laboratories Inc., Pomona, N.Y. Since the launch was announced, branded companies have waged all-out war on state and federal legislative fronts. At issue is whether authorization from the prescriber is required before an NTI drug can be substituted with a generic product.
"DuPont Merck first tried to get the Food & Drug Administration and United States Pharmacopeia to change their standards for generic products. When that failed, their strategy was to lobby state legislators for NTI antisubstitution laws," Mayr explained. As a result of those efforts, three states-North Carolina, Texas, and Virginia-have passed legislation on generic substitution for NTI drugs.
Only one state has implemented the regulations. The Virginia law took effect in July but requires the state pharmacy board to develop regulations on NTI substitution. The legislation in Texas also directs the state board to take up the issue. Current Texas law affects only refill Rxs that are written generically; for these, the R.Ph. needs authorization to change the drug's manufacturer. "If the prescription is for an NTI, the pharmacist must dispense the same generic unless a change is authorized by the physician and the patient is informed," said Paul Davis, executive director of the Texas Pharmacy Association, in Austin. "We opposed the bill because we don't see any generic products that should be subject to antisubstitution rules."
The North Carolina law represents a real blow for generics. Passed in April, it calls for the pharmacy board to compile a list of NTI drugs that R.Ph.s may not substitute without calling the physician. The difference is that the board is actually required to devise a list of NTI drugs. "The list should include six to eight drugs, and we expect the lobbying to be intense once it's compiled," said Alfred Mebane, executive director of the North Carolina Pharmaceutical Association, in Chapel Hill.
Despite massive lobbying by the branded companies, therefore, it appears that only North Carolina will limit NTI substitution. …