This site is intended for health professionals only

Plan to block drug copies slammed


Preventing generic copies of brand-name drugs from being produced in America would increase costs by more than $29 billion (£16.4 billion) over 10 years, according to an industry body in the US.

So-called generic carve-out legislation to exempt certain classes of drugs from substitution laws would also provide no safety or clinical benefit for patients, the Pharmaceutical Care Management Association (PCMA) has said.

PCMA president and CEO Mark Merritt said: “In this economy, the worst thing you can do is pursue policies which increase the cost of prescription drugs for payers and patients alike.

“The Food and Drug Administration, medical groups, and others maintain that generic substitution for all drug classes is safe and clinically appropriate.

“Generic carve-out legislative proposals that would grant special protections to brand name drug manufacturers would have no clinical benefit for patients and would unnecessarily increase costs for consumers and payors by $29 billion in the coming decade.”

Generic carve-out legislation would undermine the ability of pharmacists to substitute generic drugs in place of brand versions in certain drug classes.

Many brand name drugs in these classes will soon face generic competition. Carve-out measures would protect these brands from competition by forcing pharmacists to contact doctors for consent before substituting the generic product, even when the doctor has not indicated that a brand is medically necessary.

The onerous requirement could cause delays for patients in need of their medications.

Copyright PA Business 2008


Be in the know
Subscribe to Hospital Pharmacy Europe newsletter and magazine