Congress hopes to extend this bipartisan swoon with more healthcare legislation, this time aiming at speeding up the approval of new medicines.
The House expects to consider by this summer legislation as part of the 21st Century Cures Initiative intended to speed up development of new cures and spur research. The effort comes as Republicans and Democrats joined President Obama on Tuesday to celebrate passage of a new law that revamps how doctors are paid through Medicare.
Rep. Fred Upton, R-Mich., chairman of the key House Energy and Commerce Committee, said earlier this week that he wants to have an agreement by the end of the month, get it to the House floor by early June, and approved by the end of 2015.
The effort initially started last year with a series of roundtables where lawmakers from both sides of the aisle discussed problems facing pharmaceuticals from getting to market.
However, some Democrats were wary of draft legislation released in January.
Rep. Diana DeGette, D-Colo., a member of the committee and a leader of the initiative, declined to endorse it.
“While I don’t endorse the draft document, I know that with continued engagement, we can reach a bipartisan consensus to help advance biomedical research and cures,” she said at the time.
One controversial part of the legislation was more marketing exclusivity for brand-name specialty drugs. Such drugs, which treat serious disease such as hepatitis C, HIV or cancer, would get 15 years instead of five, according to the draft.
Exclusivity is different from a patent, which often don’t expire for 20 years. Patent protection is essentially another layer of protection from generic competition.
Patents can encompass a wide range of claims surrounding a drug, while exclusivity basically means the drug maker has a monopoly for that product for a period of time, according to the Food and Drug Administration.
The exclusivity awarded differs based on the drug. A new drug gets five years while a drug that treats rare diseases gets seven years of exclusivity, the agency said.
Supporters see the higher exclusivity limits as needed incentives to help drug makers recoup their investment. The average cost to develop a drug is more than $2.5 billion, according to a 2014 study from Tufts Center for the Study of Drug Development.
The battle over exclusivity comes as specialty drugs are accounting for more and more spending from health plans. Medicare last year spent $4.5 billion on specialty hepatitis C drugs compared to $286 million in 2013, according to ProPublica.
More exclusivity wasn’t the only issue. Rep. Frank Pallone, D-N.J., complained in January that the bill doesn’t “give any real dollars” to the National Institutes of Health for research.
The bill does want to give grants to younger researchers. Currently the federal government can’t give out grants to researchers younger than about 40.
Democrats weren’t the only ones with reservations about the package. Former FDA Commissioner Margaret Hamburg has worried that the bill will roll back agency regulations for safety and effectiveness in favor of getting drugs to market faster.
The Senate is also looking at the issue of medical innovation but hasn’t introduced any bills. The Senate Committee for Health, Education, Labor and Pensions will hold a hearing next Thursday on innovation.
