This is in response to a July 25, 1984, request by Mr. Dave Beier of your Subcommittee staff for information regarding the relationship between patent laws and enforcement of the Federal Food, Drug, and Cosmetic (FD&C) Act.
As you may know, in January 1979 the Food and Drug Administration
(FDA) published a proposal to amend its public information regulations
to include a list of approved prescription drug products for
therapeutic equivalence. The term "Approved prescription drug
products" refers to prescription drug products approved by FDA through
new drug applications (NDA's) or abbreviated new drug applications
(ANDA's) under the provisions of section 505 of the FD&C Act (21 U.S.C.
355) or, in the case of antibiotics, through analogous applications,
known as Form 5's or Form 6's under section 507 of the FD&C Act (21
U.S.C. 357).
In response to that proposal, FDA received more than 100 comments
addressing points covered in the proposal. Among the comments was one
that stated that FDA should not evaluate as therapeutically equivalent
drug products that infringe patents because including such drugs on the
list violates constitutional prinicples as well as patent laws and
discourages discovery and disclosure of new inventions. Another
comment said that a pharmacist relying on the list may be sued for
selling an unlicensed generic product. Therefore, the list should
mention that FDA does not consider the patent status of drugs.
After reviewing all comments, including the two mentioned above, FDA
published a Final Rule on this subject in the October 31, 1980, Federal
Register, Volume 45, No. 213, page 72582. In the preamble to that
Final Rule, FDA addressed all the comments, including the two
previously mentioned. The preamble stated that "The patent laws do not
have any bearing on the enforcement of the Federal Food, Drug, and
Cosmetic Act, and the agency does not consider these laws when