The Patent Doc blog notes that both the House of Representatives and the Senate have written letters to the FDA explaining their intent in inserting a 12 year period of data exclusivity for biologics in the recent healthcare reform act.
Perhaps amazingly, both legislative bodies agree! The message to the FDA is that innovator drug makers were NOT granted market exclusivity for biologics. They were granted data exclusivity - meaning a follow on manufacturer could not cite the original data filed with the FDA to support safety, purity and potency for the follow on until 12 years had passed. However, nothing precludes the follow on manufacturer from submitting their own data.
With regard to so-called "evergreening", both letters remind the FDA that the Act does prohibit it from granting more than one period of data exclusivity to the innovator.
The Act explicitly precludes any period of data exclusivity for the following:
o A supplement to a BLA; or
o A subsequent BLA (from the same company) for a non-structural change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or
o A subsequent BLA (from the same company) for a structural change that does not result in a change in safety, purity or potency.
The letters from the House and the Senate close with a statement that "the Act provides incentives for innovators to research and develop new treatments for patients," including an innovator company that "modifies an approved product to produce a change in safety, purity or potency. Approval of such a new drug will not change the data exclusivity for the "first-generation" product. The new product will be entitled to its own 12-year data exclusivity period like all new biologic drug products.
After all this bluster and discussion, the Patent Doc blog notes that the FDA is not bound to follow any of the so-called intent expressed in either letter, nor is a Court bound to interpret the law based on the intent expressed in either letter. But at least there is consensus on something - even if it may be no more than a howling wind full of sound and fury, signifying nothing.
You can also read some more coverage on these letters published in today's WSJ Health.
Posted by Bruce Lehr Jan 12th 2011.