Magazine article Drug Topics

FDA Nominee Hints Case Could Be Made for NTI Rx-Switch Notice

Magazine article Drug Topics

FDA Nominee Hints Case Could Be Made for NTI Rx-Switch Notice

Article excerpt

FDA commissioner nominee Jane E. Henney said that R.Ph.s should not be required to inform M.D.s if they switch a patient from a brand-name product to a generic, but she suggested that narrow therapeutic index Rxs might be treated differently.

"It seems to me that if the drugs are rated therapeutically equivalent, the substituted drug can be expected to perform the same as the drug for which the prescription was written," said Henney, an oncologist, in response to written questions from the Senate Labor & Human Resources Committee. "I have not had the opportunity to determine whether, given the similarity in performance of the drugs, there are other reasons physicians should be notified of modifications to prescriptions. There may be a stronger case for notification where the modification involved drugs that have a narrow therapeutic index." (A judge in Texas has blocked implementation of a law that requires R.Ph.s to inform M.D.s and patients if they intend to substitute any of nine NTI Rxs. A temporary restraining order was granted at the request of Barr Laboratories pending a hearing.)

Henney said that, if confirmed by the Senate, she did not plan to change FDA's position on bioequivalency and the suitability to substitute AB-rated generics, although she left the door open for discussions. …

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