Would-be makers of rare disease meds, rejoice: A 6-month exclusivity extension, proposed last year in Congress, has returned. The 21st Century Cures Act, now under consideration in the House of Representatives, once again includes a measure that would prolong competition-free marketing for some meds repurposed to treat rare diseases.
U.S. lawmakers have asked the U.S. Trade Representative's office to put Canada on a "priority watch list" because it has invalidated patents on drugs made by Eli Lilly and others.
Democratic lawmakers in both houses of Congress are backing a new bill extending Medicaid-style rebates to low-income Medicare patients, saying the provision would save $141.2 billion.
It turns out that compounding pharmacies that operate like small drug manufacturers can provide their owners with Big Pharma kinds of compensation. At least that was the case with New England Compounding Center, the company linked with a deadly meningitis outbreak.
As FDA Commissioner Margaret Hamburg prepared to testify before Congress about the deadly meningitis outbreak, reports surfaced that the agency wanted to shut New England Compounding Center down to fix manufacturing violations in 2003, but deferred to state regulators who apparently dropped the ball.
The Federal Trade Commission has a powerful new ally in its quest to quash "pay to delay" patent settlements: The American Medical Association. As Forbes reports, the doctors' association now officially supports legislation to outlaw the practice.
Congress is again taking a hard look at the FDA and its plant oversight methods.
Congress is again taking a hard look at the FDA and its plant oversight methods as House and Senate committees will hold hearings on the agency's actions related to the compounding pharmacy tied to a national, and deadly, outbreak of fungal meningitis.
The drumbeat is getting louder to have the FDA regulate at least those compounding pharmacies that are operating like small-scale manufacturers. And the FDA is singing the chorus saying if Congress is ready for that kind of oversight, it is prepared to take it on.
Understanding what's included in the FDA Safety and Innovation Act (FDASIA) and its ramifications for the larger medical products market will be critical to preparing for the implementation of the law in October.