In the afterglow (or for some, aftermath) of the election, PostScript thought it was worth scanning the federal policy horizon for any Rx out there.
And it’s hard to say anything about prescription drug policy in the next Congress without first talking about health reform.
With an early break from the gate, Senate Finance Committee Chair Max Baucus (D-MT) released a white paper last week entitled “Call to Action: Health Reform 2009.” The paper was the first look at an issue that lawmakers and President-elect Obama have both named as a priority when Congress reconvenes. It included provisions for comparative effectiveness, coverage-guarantee for those with pre-existing conditions, and would allow people age 55-64 to buy into Medicare early.
While passing health care reform is going to take broad consensus, and others such as Sen. Edward Kennedy (D-MA) and President-elect Obama are working on comprehensive plans of their own, we were encouraged to see that the Baucus paper recommends public disclosure of the financial relationships between industry and the medical profession. The paper referenced the recommendations MedPAC approved last week (see our earlier post) as well as S.2029, the Physician Payments Sunshine Act, though it doesn’t recommend specific reporting thresholds as MedPAC and PPSA have.
And right after Who Will Be the Next Commish, a little game being played at all the right blogs and Beltway dinner parties this season, we see two major FDA questions facing the Congress in its next term:
Q: With drugs coming from everywhere on the planet, how do we make sure they are safe enough to go into American medicine cabinets?
(Probable) A: The FDA Globalization Act. Ever since the heparin-from-China scare of 2008, interest in having a better handle on where our drugs are coming from and a bill that would shore up oversight, require new country-of-origin labeling, provide more resources for inspections of foreign manufacturing plants, and grant the agency subpoena power many other federal agencies charged with protecting the public already have. Both a House and Senate version were introduced in 2008.
Q: What happens to biotech drugs after the patent runs out?
(Right now) A: Nothing, and that’s an expensive answer both for consumers and the future of the drug pipeline, as R&D turns more and more to biologic therapies. Currently, four draft bills on the creating a pathway for biogenerics (also called “follow on biologics”) are circulating. The version introduced by Rep. Henry Waxman (D-CA) is widely considered to be the most consumer-friendly.
Only 64 days till the 111th is sworn in, so stay tuned – we sure will.