Congressional Health Policy Hearings & Markups

On May 8, 2013, the House Energy and Commerce Subcommittee on Health approved by voice vote H.R. 1407, legislation to reauthorize and combine the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act. TheEnergy and Commerce Committee also recently held hearings on: the Administration’s HHS budget proposal; the Center for Consumer Information and Insurance Oversight and implementation of the ACA; the lack of transparency and consumer driven market forces in U.S. health care system; and the impact of HIPAA on patient care and public safety. The House Ways and Means Health Subcommittee held a hearing on Medicare physician payment reform, and the Senate Finance Committee has scheduled a May 14 hearing on this topic.  Other Senate panels also recently held hearings on health policy issues, including: a HELP Committee hearing on "Successful Primary Care Programs: Creating the Workforce We Need"’ a Homeland Security Committee hearing on “Oversight and Business Practices of Durable Medical Equipment Companies”; and a Special Committee on Aging hearing on "The National Plan to Address Alzheimer's Disease: Are We On Track to 2025?"

April Congressional Health Policy Hearings & Markups

Earlier this month, the Senate Finance Committee held a hearing on the nomination of Marilyn Tavenner to be CMS Administrator. The Senate Health, Education, Labor, and Pensions (HELP) Committee approved the Mental Health Awareness and Improvement Act, legislation that reauthorizes and amends programs administered by both HHS and the Department of Education related to awareness, prevention, and early identification of mental health conditions. The HELP Committee also held a hearing on the effect of guaranteed issue and new insurance rating rules. A House Ways and Means Committee hearing focused on details of the President’s FY 2014 budget proposals for HHS programs. The House Energy and Commerce Committee held hearings on the ACA’s Pre-Existing Condition Insurance Program, reauthorization of FDA animal drug user fees, and “Challenges of Traditional Medicare's Benefit Design.” The Energy and Commerce Committee also plans an April 16 hearing on the fungal meningitis outbreak and whether it could have been prevented, along with an April 18 hearing on the Administration’s HHS budget proposal.

President Signs Government Funding Bill Maintaining FY 2013 Medicare Sequestration Cuts

On March 26, 2013, President Obama signed into law H.R. 933, a continuing resolution  that averts a government shutdown by funding the government through the remainder of fiscal year 2013 (through September 30, 2013). The funding bill is subject to the sequestration order triggered by the Budget Control Act, although funding was increased for a limited number of HHS programs (including funding for community health centers and certain National Institutes of Health activities). The funding bill keeps in place the 2% Medicare provider cuts triggered under the Budget Control Act’s sequestration provisions. It also authorizes the Food and Drug Administration to continue collecting industry user fees to fund agency operations.

Senate HELP Committee Approves Organ Transplant, Animal Drug User Fee Bills

On March 20, 2013, the Senate Committee on Health, Education, Labor, and Pensions approved an amended version of S. 330, a bill to amend the Public Health Service Act to establish safeguards and standards of quality for research and transplantation of organs infected with human immunodeficiency virus (HIV). Among other things, the bill would remove the ban on research of organ transplantation from HIV-positive donors to HIV-positive recipients. If such research shows that these transplants can be conducted safely, the bill authorizes organ donation standards to be updated accordingly.  The panel also approved an original bill to reauthorize the Animal Drug User Fee Act and Animal Generic Drug User Fee Act. 

FDA Announces 2013 Generic Drug Active Pharmaceutical Ingredient and Finished Dosage Form Facility User Fee Rates

This post was written by Jennifer Pike.

The FDA has announced the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facility user fee rates for fiscal year 2013. The API facility fee is owed by each person that owns a facility which produces, or which is pending review to produce, one or more APIs identified, or intended to be identified, in at least one generic drug submission that is pending or approved or in a Type II API master file referenced in such generic drug submission. The API facility fee for 2013 for domestic facilities is $26,458, while the API facility fee for foreign facilities is $41,458. The FDF facility fee is owed by each person that owns a facility which is identified or is intended to be identified, in at least one generic drug submission that is pending or approved, to produce one or more finished dosage forms of the human generic drug. The FDF facility fee for 2013 for domestic facilities is $175,389, and the FDF facility fee for foreign facilities is $190,389. Both API and FDF fees are due on March 4, 2013. FDA is authorized to collect these fees, among others, under the Generic Drug User Fee Amendments of 2012.

FDA Requests Comments on Review of Medical Device Submissions

This post was written by Jennifer Pike.

The FDA has announced an opportunity for public comment on the statement of work for an assessment for the process of review of medical device submissions. Under the Medical Device User Fee Act of 2012 (MDUFA III), which gives FDA the authority to collect device user fees from industry for 2013-2017, FDA has committed to reaching certain performance goals. Among others, FDA is committed to participate, with the device industry, in a comprehensive assessment of the process for the review of device applications. The assessment will be conducted in two phases by a private, independent contractor. FDA is providing a comment period on the statement of work before requesting proposals for the assessment. Comments should be submitted in writing or electronically, at www.regulations.gov, by February 4, 2013.

FDA Issues Generic Drug User/Backlog Fee Notices

This post was written by Jennifer Pike.

On October 25, 2012, the Food and Drug Administration (FDA) published in the Federal Register the fiscal year (FY) 2013 rates for certain filings under the Generic Drug User Fee Program. Specifically, the notice establishes the new annual rates for an abbreviated new drug application (ANDA) ($51,520), prior approval supplement ($25,760), and drug master file ($21,340). These fees are effective on October 1, 2012 and remain in effect through September 30, 2013. The fees for the ANDA and prior approval supplement are due by the applicant on the date of submission, or 30 days after the published notice (i.e. November 24, 2012), whichever is later. The drug master file (DMF) fee is owed by each person that owns a type II active pharmaceutical ingredient drug master file that is referenced, on or after the effective date in a generic drug submission by an initial letter of authorization. This one-time fee for each individual DMF is due no later than the date on which the first generic drug submission is submitted that references the associated DMF, or 30 days after the published notice (i.e. November 24, 2012), whichever is later.

Also on October 25, 2012, FDA published the 2013 rate for the backlog fee related to generic drug user fees. The backlog fee of $17,434 is effective on October 1, 2012. Each person that owns a pending ANDA on October 1, 2012 -- i.e., an ANDA submission that has not received tentative FDA prior approval to the effective date -- is subject to the backlog fee for each such application. The backlog fee is a means for FDA to generate enough resources to process its backlog of ANDAs. FDA currently has an approximate backup of over 2,800 ANDAs. The backlog fee is due no later than 30 days after the published notice (i.e. November 24, 2012).

Generic Drug User Fee Fix Cleared by Congress

On September 21, 2012, the Senate joined the House in approving H.R. 6433, the FDA User Fee Corrections Act of 2012. The bill would allow the FDA to collect all generic drug user fees authorized by the recently-enacted FDA Safety and Innovation Act for FY 2013, rather than a reduced level of fees allowed under the short-term funding bill also cleared by Congress on September 21. H.R. 6433 is now awaiting the President’s signature.

Draft Guidance Regarding Self-Identification of Generic Drug Facilities and Q&A on Generic Drug User Fee Amendments

This post was written by Erin Janssen.

On August 27, 2012, FDA issued draft guidance documents for industry entitled "Self-Identification of Generic Drug Facilities, Sites, and Organizations" and "Generic Drug User Fee Amendments of 2012: Questions and Answers." The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. The GDUFA also is designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, and enable FDA to assess user fees to support enhancements to FDA’s generic drugs program. The first draft guidance document is intended to assist industry as it prepares to meet the law’s self identification requirement. It explains who is required to self-identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify. The second guidance document answers common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. To be considered before FDA begins work on the final versions of these documents, comments should be submitted by October 26, 2012.

FDA Establishes FY 2013 User Fee Rates for Biosimilars and Prescription Drugs

This post was written by Erin Janssen.

The Food and Drug Administration (FDA) has announced the rates for biosimilar and prescription drug user fees for FY 2013. By way of background, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product and prescription drug development, for certain applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological product products are made, and on biosimilar biological products after approval. The FY 2013 rates for both biosimilar and prescription drug fees are as follows: initial and annual fees -- $195,880; reactivation fee -- $391,760; fee for a product application requiring clinical data -- $1,958,800; fee for a product application not requiring clinical data -- $979,400; fee for a product supplement requiring clinical data -- $979,400; product establishment fee -- $526,500; and product fee -- $98,380. These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013. 

FDA Guidance on FY 2013 Medical Device User Fee Small Business Qualification and Certification

This post was written by Erin Janssen.

The FDA has issued guidance on FY 2013 medical device user fees for small businesses. The guidance explains how a business may qualify as a “small business” and pay most FY 2013 medical device user fees at substantially discounted rates. While the guidance is substantively the same as the guidance provided for FY 2012, the following new considerations are particularly significant:

  • The guidance explains that there is no small business discount for the establishment registration fee. If this is the only fee a business expects to pay during FY 2013, it should not submit an FY 2013 Small Business Qualification Certification.
  • A foreign business may qualify as a small business, even if it has not submitted a federal (U.S.) income tax return.

As of September 30, this document supersedes “Guidance for Industry, FDA, and Foreign Governments: FY 2012 Medical Device User Fee Small Business Qualification and Certification,” as issued on May 25, 2012.

Medical Device User Fee Rates for FY 2013

This post was written by Erin Janssen.

On July 31, 2012, the FDA published the fee rates and payment procedures for medical device user fees for FY 2013. The fee rates apply from October 1, 2012 through September 30, 2013. To avoid delay in the review of an application, the fee should be paid before or at the time the application is submitted to FDA. The standard fee for a premarket application is $248,000 for FY 2013. More information about the FY 2013 fees can be found at the FDA web site.

Congress Clears FDA Safety & Innovation Act

On June 26, 2012, the Senate gave final approval to S. 3187, the Food and Drug Administration Safety and Innovation Act, following House action on June 20, 2012. The sweeping, bipartisan legislation would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and authorize user fee programs for generic drugs and biosimilar drugs. As part of the drug and device user fee reauthorization process, the FDA would commit to certain performance goals and to fostering more interaction and predictability between industry and FDA during the review process. In addition, the bill would, among other things: take a variety of steps to alleviate drug shortages and protect the drug supply chain (although it does not include a national track-and-trace program); permanently authorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; offer incentives for the development of new qualified infectious disease products; promote expedited review of “breakthrough therapy” drugs; and make a variety of FDA administrative reforms. The President is expected to sign the bill. 

House, Senate Approve FDA User Fee/Drug Safety Bills

On May 30, 2012, the House of Representatives voted 387-5 to approve H.R. 5651, the Food and Drug Administration Reform Act. The House bill would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and authorize user fee programs for generic drugs and biosimilar drugs. As part of the drug and device user fee reauthorization process, the FDA would commit to certain performance goals and to fostering more interaction, predictability, and certainty between industry and FDA. In addition, the bill would: take a variety of steps to protect the drug supply chain and alleviate drug shortages; permanently authorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; make a variety of FDA administrative reforms (including changes to the guidance process and conflict of interest rules); and revise the medical device and drug review processes. On May 24, the Senate approved its version of the legislation, S. 3187, the Food and Drug Administration Safety and Innovation Act, by a vote of 96-1. A conference committee will be appointed to resolve differences between the House and Senate versions of the bills. 

House Panel Unanimously Approves FDA User Fee Act

On May 10, 2012, the House Energy and Commerce Committee unanimously approved H.R. 5651, the Food and Drug Administration Reform Act. The legislation would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and it authorizes user fee programs for generic drugs and biosimilars. As part of the drug and device user fee reauthorization process, the FDA would commit to certain performance goals and to fostering more interaction, predictability, and certainty between industry and FDA. In addition, the bill: permanently authorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; makes a variety of FDA administrative reforms (including changes to the guidance process and conflict of interest rules); make various reforms to the medical device and drug review processes; and take steps intended to alleviate drug shortages. On April 25, the Senate Health, Education, Labor and Pensions (HELP) Committee also approved bipartisan legislation, the Food and Drug Administration Safety and Innovation Act, to authorize FDA user fees and address drug supply chain and drug shortage issues.

April Congressional Health Policy Hearings and Markups

The House Energy and Commerce Committee Health Subcommittee recently held a hearing on “FDA User Fees 2012: How Innovation Helps Patients and Jobs,” focusing on reauthorization of the Prescription Drug User Fee Act and the Medical Device User Fee Act.  In addition, the Senate Aging Committee examined the “Future of Long-Term Care: Saving Money by Serving Seniors." The Senate Budget Committee also has begun to debate a long-term budget proposal based on the bipartisan Fiscal Commission plan, also known as the Bowles-Simpson plan.  Looking ahead:

Congressional Hearings on Drug Issues.

Recent health policy hearings include a House Judiciary Committee Crime Subcommittee hearing on “The Prescription Drug Epidemic in America” and a House Energy and Commerce Health Subcommittee hearing on “FDA User Fees 2012: Issues Related to Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain.”

FDA and Industry Reach Agreement in Principle on Medical Device User Fees

This post was written by Erin A. Janssen and Kevin M. Madagan.

The FDA and representatives from the medical device industry reportedly reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program, according to an announcement released February 1, 2012 on the FDA's website. FDA claims the agreement “strikes a careful balance between what industry agreed to pay and what the FDA can accomplish with the amount of funding proposed. It would result in greater accountability, predictability and transparency through such improvements as a more structured pre-submission process and earlier interactions between FDA and applicants.” The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

February Congressional Health Policy Hearings

The House Energy and Commerce Health Subcommittee has held hearings on reauthorization of the Prescription Drug User Fee Act and generic and biosimilar user fees, and an additional hearing on reauthorization of Medical Device User Fee Act is scheduled for February 15, 2012.  The House Ways and Means Health Subcommittee held a hearing on how private sector payers are rewarding physicians who deliver high quality and efficient care.  Looking ahead, on February 14, the Senate Health, Education, Labor and Pensions Committee is holding a hearing on“Pain in America: Exploring Challenges to Relief.” 

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