TAPP Urges U.S. Senate Judiciary Committee to Oppose S. 150 - "A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes."

The Trade Alliance to Promote Prosperity has written a letter to members of the U.S. Senate Judiciary Committee, urging them to protect American intellectual property rights and oppose S. 150, "A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes," which would put at risk U.S. global leadership in medical and biopharmaceutical research and development (and thus also patients). 

In the letter, TAPP wrote the following:

Under S. 150, follow-on innovations that Americans have traditionally taken for granted—including new drug formulations, new drug delivery methods, drug versions with fewer side effects, drug regimens that are easier to follow, drug versions that are easier to take, etc.—would suddenly be at risk of facing unreasonable antitrust scrutiny, red tape, and regulation by the FTC.

The bill would create an unacceptable presumption of anticompetitive behavior for biopharmaceutical inventions that Americans have come to expect and rely on. As such, the bill would cast a chill over the post-R&D investment environment and thus put at risk future efforts to invent, develop, and produce much-needed therapies and drugs.

The bill would basically freeze innovation by presuming that changes to a drug or therapy or selling a follow-on product would be anticompetitive. Yet isn’t it just common sense that once a drug or therapy is developed, there should be additional research on those products to discover new and different benefits to patients? Yes, it is. We should be encouraging such research!

It’s important to note that, contrary to bill supporters’ claims, the intellectual property protection on post-approval advances does not block approval of generic copies or biosimilar versions of earlier-approved drugs or therapies. If, as is often claimed, a manufacturer were to introduce an insignificant change to an existing drug/therapy, that change would do nothing to impact FDA approval of generic/biosimilar versions of the earlier drug/therapy. Existing intellectual property protections would become uncertain under S. 150. This would have a chilling effect on pharmaceutical innovation and would imperil American patients with unmet medical needs who are desperately waiting and hoping for new treatments and cures.

Finally, S. 150 is unclear about what would constitute an anticompetitive “product hop.” The standards outlined in the bill are frustratingly broad and vague. How would an innovator evaluate whether an action would “unfairly disadvantage” an earlier product and thus be able to avoid running afoul of the law short of ceasing innovation altogether? The bill is unhelpful in answering this question.

U.S. medical innovation relies on intellectual property protection to be the most advanced in the world. S. 150 would trample on intellectual property rights and put American doctors and patients at a global disadvantage. Indeed, S. 150 would put in danger the very patients it seeks to help.

That’s why we at the Trade Alliance to Promote Prosperity are urging you to oppose S. 150.