Medical Device User Tax (MDUFA) Cleared by the House Subcommittee

In an early act of compromise and success, the Medical Device User Fee Act (MDUFA), a part of proposed healthcare reform, was drafted and tentatively cleared by a subcommittee composed of FDA representatives, members of the House of Representatives and medical technology stakeholders last month. The MDUFA is the third generation of of this kind of regulation, act as medical technology, clinical procedure and patients’ needs change with modernization. The purpose of redrafting the MDUFA is in the hopes that patients can benefit from the latest innovations in medical technology more readily and manufacturers can benefit from a more transparent and expedited FDA approvals process.

The largest point that the med-tech industry and the FDA had to come to terms with was the amount of user fees the medical device industry had to pay for agency reviews. A tentative agreement of doubling the existing fees, from 295 million to 595 million over the next five years, was the approved agreement. The medical device industry pays this increase in fees in exchange of quicker and more efficient FDA approvals. This piece of healthcare reform is an important compromise for both the medical industry and the agency. The medical device industry benefit from a more transparent and predictable approvals process, enabling manufacturers to supply life-saving equipment, as the FDA benefits from the increase in resources to make the approvals process more effective and efficient. In the end, this more streamlined scenario will benefit the patient with the availability of innovative medical devices.

Although the fees have doubled for medical device makers, the early industry-agency agreement has support from most device makers and medical lobbyists, including members of Boston Scientific and Medtronic. It seems that most in the industry agree that the potential of faster approvals by the FDA, regardless of the increase in user fees, will increase future revenue as faster approvals can mean faster manufacturing.

The proposed MDUFA draft will now be reviewed by the Committee of Energy and Commerce in The House of Representatives. The proposed piece of healthcare reform will also provide a 30-day period of public comment, and the committee will make changes as necessary before ultimately going before Congress.

Image courtesy of: Leader Nancy Pelosi Flickr