Study Argues for Protection of Incremental Drug Advances
D.C., April 9, 2009—New
pharmaceuticals drugs – even when they are very similar to existing drugs –
should be allowed to compete freely with other products and not be subject to
discriminatory government treatment by regulators or in federal health programs,
according to a new study published by the Competitive Enterprise Institute.
The study, Pharmaceutical
Evolution: The Advantages of Incremental Innovation in Drug Development,
the value of so-called “Me-too” drugs – those within the same chemical class as
one or more others already on the market. Despite their similarity to existing
treatments, Me-too drugs can provide significant benefits to patients and
“Drugs based on incremental improvements generally represent advances in safety
and efficacy, and facilitate more personalized prescribing alternatives. They
also provide new formulations and dosing options that significantly increase
patient compliance, which also lead to improved health outcomes,” write study
authors Albert I.
Wertheimer and Thomas M.
Santella. “Patients respond differently to different drugs within a single
class. If physicians have many options at their disposal, they can calibrate
their prescribing patterns to better address the needs of specific patients.”
Members of Congress such as powerful
House Commerce Committee chairman Henry Waxman (D-CA) have questioned the need
for multiple drugs in the same class, suggesting that government programs like
Medicare should try to economize by favoring only a few popular treatments,
undermining the development and profitability of Me-too drugs.
“From an economic standpoint,
adding new drugs to a class of medicines also offers the possibility of lower
drug prices as competition among manufacturers increases,” write Wertheimer and
Santella. “Put simply, limiting incremental drug innovation is analogous to
limiting competition. The ultimate result could have devastating consequences
for the future of the pharmaceutical industry and for the millions of patients
who depend on it.”
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public policy group dedicated to the principles of free enterprise and limited
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