User Fee Act Passes Senate Panel While Tensions Escalate in the House
The Senate's Health, Education, Labor and Pensions (HELP) Committee passed a collection of user fee acts in a piece of legislation known as the Food and Drug Administration Safety and Innovation Act (FDASIA), advancing the bill for an eventual vote before the entire Senate.
The 25 April HELP Committee markup process for FDASIA saw a flurry of activity in both the House and Senate. Regulatory Focus summarizes that activity for you here:
The Hill: The Senate's HELP Committee passed the FDASIA legislation, including provisions to fast-track treatments intended to treat rare or serious diseases.
Politico: The House of Representatives does not appear to be willing to compromise on their user fee legislation, leading to the airing of hostilities in the chamber.
Regulatory Focus: Differences in the Senate's user fee bill (FDASIA) and the House of Representatives' version of the bill are threatening to derail the entire legislative process, reports Politico.
House of Representatives: The House Energy and Commerce Committee's Chairman of the Subcommittee on Health, Joe Pitts, unexpectedly moved the House's markup process from 26 April to 8 May 2012.
Regulatory Focus: Track and trace anti-counterfeiting measures did not make it into the final FDASIA bill in the Senate, and it is increasingly unlikely that provisions will make it into the House bill as well after concerns about the costs associated with the program have kept industry in opposition.
The Pink Sheet Daily: A number of provisions that would strengthen the US Food and Drug Administration's (FDA) powers to destroy seized counterfeit products seemed to have stalled in the Senate version of the user fee markup.
The Star Tribune: A push by some prominent Senators to allow for drug re-importation fell short of passage as their amendment was defeated 12-9.
The National Journal: The Senate markup process was remarkable in how smoothly it went. The House process may well be the exact opposite as disagreements over medical device approval language proves to be a sticking point.
Mass Device: The bill includes provisions for stronger postmarketing surveillance for medical devices.
Cystic Fibrosis Foundation: Inclusion of the Expanding and Promoting Expertise in Review of Rare Treatments Act in the Senate legislation is laudable.
Consumers Union: Lack of medical device safeguards in the Senate legislation puts patients at risk.