The Eshoo version of protecting patients and data exclusivity for new biotech drugs sailed through the Waxman controlled Energy and Commerce Committee...
"One of the mark-ups was an amendment offered by Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) that is similar to the follow-on biologics legislation (H.R. 1548) Rep. Eshoo (at left) introduced in March. In particular, the amendment outlines a licensure pathway for biosimilar biological products that includes a provision preventing the FDA from approving a biosimilar application until 12 years after the date on which the reference product (i.e., the innovator biologic) was first licensed. The amendment was passed by the Committee by a comfortable 41-11 margin. Voting against the amendment were Chairman Waxman and Representatives Dingell, Frank Pallone, Jr. (D-NJ), Lois Capps (D-CA), Janice Schakowsky (D-IL), Anthony Weiner (D-NY), Kathy Castor (D-FL), John Sarbanes (D-MD), Betty Sutton (D-OH), Peter Welch (D-VT), and Nathan Deal (R-GA). The votes by Representatives Pallone, Capps, Schakowsky, and Sarbanes were not altogether surprising, given that the four Committee members are co-sponsors of Chairman Waxman's H.R. 1427, which provides up to 5.5 years of exclusivity (as of Friday, Chairman Waxman's bill had the support of 14 co-sponsors while Rep. Eshoo's bill enjoyed the support of 142 co-sponsors)."
The bad news....
House Compromise Would Let Medicare Negotiate Drug Prices
"The government would be authorized to negotiate prices in Medicare’s prescription drug program under an agreement Energy and Commerce Committee Democrats struck Friday on its health overhaul bill.
The panel, rushing to finish its part of the huge bill before leaving later in the day for the August recess, was expected to vote on the drug pricing provision as part of a package of amendments aimed at satisfying the competing demands of liberal and conservative Democrats...." .....The second amendment, according to a summary of the agreement, would make a number of less controversial changes to the bill, including requiring that the public plan use a formulary to control its drug cost. The third amendment would authorize HHS to negotiate drug prices paid by Medicare — something long fought by the pharmaceutical industry. The amendment also would require insurance plans selling policies through a new “exchange” created by the bill to request permission from the government before increasing their premiums faster than the rate of medical inflation, one lawmaker said.
Read article here.
Price controls. Not controversial?
Meanwhile in an announcement that was striking for it's coincidence....
Agencies Seek to Use Stimulus Funds to Find Cheaper Health Care
By JANE ZHANG
"Federal health agencies, seeking to hand out stimulus funds to research the effectiveness of various medical treatments, said they will include projects that look in part at the cost of drugs and other treatments.
The approach -- which was unveiled in a report to Congress this week by the Agency for Healthcare Research and Quality and the National Institutes of Health, both agencies under the Department of Health and Human Services -- could provide more fodder to conservatives worried that the government might use the results of such studies to limit health care to consumers.
Administration officials have said they want to use stimulus funds to help doctors and patients choose more-effective treatments and ultimately, help rein in rising health-care costs. Democrats are considering including measures that would support such research as part of health-care legislation making its way through Congress."
".... Nicholas Papas, an HHS spokesman, said under the stimulus law, Medicare can't use the research to deny coverage to patients."
Of course not! But what about delaying access to new treatments or, requiring prior authorization or paying less for covered treatments which, as research shows, leads to reduced use?
Read more here
