Pharmaspective

The Prescription Drug User Fee Act…In a Nutshell

The Prescription Drug User Fee Act (PDUFA) was originally enacted in 1992, and authorizes the federal Food and Drug Administration (FDA) to collect fees from pharmaceutical companies seeking FDA approval of new drugs and biologics.  In return for collecting fees, the PDUFA requires the FDA to meet performance benchmarks with the overall intention of making the New Drug Application review process more efficient. Since 1992, user fees collected by the FDA under the PDUFA have permitted the agency to expand its NDA review staff and considerably reduce a product’s review time while still assuring the safety of human drugs. Congress is required to reauthorize the PDUFA every 5 years by September 30^th in order to ensure the continuity of the user fee programs.

 

To this end, the United States House of Representatives has introduced House Bill 5651, which would, among other things, reauthorize the PDUFA. House Bill 5651 also provides for the reauthorization of the Medical Device User Fee Act (MDUFA), which authorizes the FDA to collect fees from medical device manufacturers seeking its approval on new medical devices. Further, House Bill 5651 would authorize two new user fee programs: the Generic Drug User Fee Act (GDUFA) to facilitate the review process for generic drugs, and the Biosimilars User Fee Act (BSUFA) to facilitate the abbreviated review of products shown to be biosimilars to an FDA-approved biologic.

 

In an effort to reauthorize the PDUFA well before the September 30, 2012, deadline, House Bill 5651 has been moving quickly through the usual legislative hurdles. To date, both the House Energy and Commerce Subcommittee on Health, and the House Energy and Commerce Committee have unanimously approved the bill. House Bill 5651 will now move to the entire House for a vote.

 

Congress’ expediency in reviewing House Bill 5651 may be attributed to its desire to reauthorize the PDUFA well before the statutory deadline.  The current version of the PDUFA was signed into law on September 27, 2007, just three days before the deadline. As the reauthorization deadline drew near without the PDUFA being reenacted, the FDA left many of its positions vacant in the event that that user fee charges were not available at beginning of the fiscal year on October 1, 2007. With thoughts of 2007 looming over their heads, supporters of the PDUFA are hoping to have House Bill 5651 enacted before the start of the upcoming fiscal year, which begins on October 1, 2012.  

 

For more information on the PDUFA, please Click Here!

 

Senators Grassley and Kohl Disappointed With The Delay In Implementing the Sunshine Act

Senators Charles Grassley and Herb Kohl, co-authors and co-sponsors of the Sunshine Act, have issued a statement in response to the announcement made by the Centers for Medicare and Medicaid Services.  Last week, CMS posted a notice that it will not require data collection by applicable manufacturers and applicable group purchasing organizations (GPOs) pursuant to the Sunshine Act before January 1, 2013.

 

The Sunshine Act, or the “Transparency Reports and Reporting of Physician Ownership or Investment Interests” section of the Patient Protection and Affordable Care Act, requires certain drug, device, biological product, and medical supply manufacturers to disclose annually information regarding payments and other transfers of value made to physicians and teaching hospitals. An additional provision requires manufacturers and GPOs to disclose all ownership or investment interests held by physicians or members of their family.

 

In December 2011, CMS issued a notice of proposed rulemaking announcing the publication of draft regulations to implement the Sunshine Act, which statutorily requires manufacturers and GPOs to begin collecting data starting January 1, 2012.  The proposed regulations suggested that this date may be postponed to 90 days after the final regulations are published. The final regulations have not been published to date.

 

Last week, CMS indicated on its official blog that it will not require data collection by applicable manufacturers and applicable GPOs before January 1, 2013. In its blog post, CMS states that it intends to release the final rule implementing the Sunshine Act later this year (2012), which will give CMS additional time to “address operational and implementation issues in a thoughtful manner,” and “ensure the accuracy of the data that is collected.” 

 

Shortly thereafter, Senators Grassley and Kohl issued statements in response to the delay. Senator Grassley noted his disappointment that CMS will not collect data at all in 2012, and his dissatisfaction that the process of implementing the Sunshine Act has exceeded the statutory deadline. Senator Grassley indicated that “consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later,” and expressed that it is “important that CMS get this right in every way, including the usefulness and accuracy of the information.” Senator Kohl also noted his disappointment with the delay, but looks forward to “working with CMS to finalize the rules so that data collection can begin in January 2013.”

 

To view the Senators’ statement, please click on the following link:

 

http://bit.ly/J7HTiR

 

To view CMS’s blog regarding implementation of the Sunshine Act, please click on the following link:

 

http://bit.ly/IyhB8n

 

CMS Announces It Will Not Require Data Collection By Applicable Manufacturers or GPOs Pursuant to the Sunshine Act Before January 1, 2013

In December 2011, the Centers for Medicare and Medicaid Services published draft regulations that would implement the “Transparency Reports and Reporting of Physician Ownership or Investment Interests” section of the Patient Protection and Affordable Care Act, commonly referred to as the Sunshine Act. Pursuant to the Sunshine Act, drug, device, biological product, and medical supply manufacturers must disclose annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires manufacturers and group purchasing organizations (GPOs) to disclose all ownership or investment interests held by physicians or members of their family.

The Sunshine Act requires manufacturers and GPOs to begin collecting data starting January 1, 2012. CMS recently indicated on its official blog, however, that it will not require data collection by applicable manufacturers or applicable GPOs before January 1, 2013. CMS states that it intends to release the final rule implementing the Sunshine Act later this year, which will give CMS additional time to “address operational and implementation issues in a thoughtful manner,” and “ensure the accuracy of the data that is collected.”

To view CMS’ blog regarding implementation of the Sunshine Act, please click on the following link:

http://blog.cms.gov/2012/05/03/information-on-implementation-of-the-physician-payments-sunshine-act/.