Tag Archives: generic drugs

OIG Assesses FDA Progress on Oversight/Inspections of Generic Drug Manufacturers

In a recent report, the HHS OIG concludes that FDA has made progress in improving oversight of generic drug manufacturers, including greater parity in inspections of foreign and domestic generic drug manufacturers. A summary of the report, FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs, is available on our Life Sciences … Continue Reading

Congressional Health Policy Hearings

Recent Congressional health policy hearings have addressed the following issues: The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on generic drug pricing; The House Oversight and Government Reform Committee focused on its concerns associated with transparency in passage and implementation of the Affordable Care Act in a hearing featuring CMS Administrator Marilyn … Continue Reading

FDA Public Hearing on the Implementation of Generic Drug User Fee Amendments (Sept. 17)

This post was written by Jennifer Pike and Vicki Morris. On September 17, 2014 the Food and Drug Administration (“FDA”) is holding a public hearing at the College Park Marriot Hotel and Conference Center, in Hyattsville, MD, to discuss the Agency’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and its obligations under … Continue Reading

April Congressional Hearings

Recent Congressional hearings on health policy issues include the following: House Energy and Commerce Committee hearings on the “Helping Families in Mental Health Crisis Act”; the FDA’s proposed changes to generic drug labeling; and legislation intended to improve predictability and transparency in Drug Enforcement Agency and FDA regulation (H.R. 4299, H.R. 4069, and H.R. 4250). A House … Continue Reading

July Health Policy Hearings

Recent Congressional hearings have addressed the following health policy issues: The House Energy and Commerce Committee has held hearings on Medicaid reform, implementation of the ACA, and reform of drug compounding regulations. An August 1 hearing entitled “PPACA Pulse Check” will feature testimony by CMS Administrator Marilyn Tavenner. The Senate Finance Committee held two hearings … Continue Reading

Obama Administration’s Proposed FY 2014 Budget Includes $401 Billion in Health Program Savings

Today, the Obama Administration released its proposed federal budget for fiscal year 2014. As widely reported, the budget incorporates an offer the President made to Congress in December 2012 to achieve nearly $1.8 trillion in additional deficit reduction over the next 10 years, including $401 billion in health savings (the Administration observes that this level of … Continue Reading

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 … Continue Reading

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 … Continue Reading

Short-Term Government Funding, FDA User Fee & Safe Doses Bills Signed into Law

President Obama has signed into law a temporary spending bill (H.J.Res. 117) to fund the government until March 27, 2013 in light of Congress’ failure to reach agreement on the regular appropriations bills before the start of the new fiscal year on October 1, 2012. In addition, on October 5, 2012, President Obama signed H.R. … Continue Reading

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 … Continue Reading

GAO Reviews Research on Generic Drug Savings

In a recent report, “Drug Pricing: Research on Savings from Generic Drug Use,” the GAO reviewed studies on savings associated with generic drug use in the U.S. In brief, the studies had mixed conclusions regarding the effect of using generics. While some studies point to substantial savings associated with substituting generic drugs for their brand-name … Continue Reading

E&C Health Subcommittee Plans FDA User Fee Hearings in February

The House Energy and Commerce Health Subcommittee has announced a series of hearings on FDA user fees for prescription drugs, generic drugs, biosimilar drugs, and medical devices. The hearing schedule is as follows: a February 1, 2012 hearing will address reauthorization of the Prescription Drug User Fee Act; on February 7, a Subcommittee hearing will … Continue Reading

E&C Health Subcommittee Plans FDA User Fee Hearings in February

The House Energy and Commerce Health Subcommittee has announced a series of hearings on FDA user fees for prescription drugs, generic drugs, biosimilar drugs, and medical devices. The hearing schedule is as follows: A February 1, 2012 hearing will address reauthorization of the Prescription Drug User Fee Act; A February 7 hearing will focus on the … Continue Reading

FDA Public Meeting on Generic Drug User Fees (Dec. 19)

This post was written by Erin Janssen. On December 19, 2011, the FDA is hosting a public meeting to discuss proposed recommendations for enactment of a Generic Drug User Fee Act (GDUFA), which would authorize FDA to collect fees and use them for the process for the review of human generic drug applications and associated Type … Continue Reading

President Obama Outlines Proposal to Deficit Reduction Super-Committee; Medicare Provisions Loom Large

On September 19, 2011, President Obama presented his deficit reduction plan - including $320 billion in proposed federal health spending cuts - to the Joint Select Committee on Deficit Reduction, which was created by the Budget Control Act of 2011 to craft a legislative package to cut the federal deficit by at least $1.5 trillion. If legislation is not adopted to achieve deficit reduction targets by January 2012, $1.2 trillion in across-the-board spending cuts (sequestration) would be triggered, effective January 2013.… Continue Reading

Congressional Panels Consider Generic Drug Promotion, Other Health Policy Legislation

On July 21, 2011, the Senate Judiciary Committee approved S. 27, the Preserve Access to Affordable Generics Act, which would prohibit certain so-called “pay-for-delay” agreements in patent litigation settlements in which a brand-name pharmaceutical company compensates a generic pharmaceutical company for delays in generic entry. On July 28, 2011, the House Energy and Commerce Committee approved … Continue Reading

July Congressional Health Policy Hearings/Markups

A number of Congressional panels have held hearings on health policy issues this month, and more are scheduled, including the following: The House Energy and Commerce Committee has held hearings on: reauthorization of the Prescription Drug User Fee Act (PDUFA); the ACA’s Independent Payment Advisory Board (IPAB), which is charged with helping to contain Medicare costs; … Continue Reading

OIG Report on Medicare Payments for Newly Available Generic Drugs

The HHS Office of Inspector General (OIG) has issued a report entitled “Medicare Payments for Newly Available Generic Drugs.” The report notes that because of the timing of manufacturer reporting of quarterly average sales price (ASP) data to CMS and when those data are used to calculate payment amounts, there is a two-quarter lag between when … Continue Reading

FDA Reopens Comment Periods on Generic Drug User Fee Program, PDUFA Reauthorization

This post was written by Paul Sheives. FDA has extended its comment period its August 9, 2010 generic drug user fee program notice from October 17, 2010 to December 6, 2010.  FDA also has extended a comment period on reauthorization of the Prescription Drug User Fee Act (PDUFA) until October 21, 2011.… Continue Reading

FDA Meeting and Request for Comments on Generic Drug User Fee Program

This post was written by Paul Sheives and Areta Kupchyk. FDA will hold a public meeting on September 17, 2010 to seek input on the development of a generic drug user fee program. Currently, FDA does not have the statutory authority to collect user fees for generic drugs. Specifically, FDA seeks comments on: (1) how the … Continue Reading

FDA Meeting and Request for Comments on Generic Drug User Fee Program

This post was written by Paul Sheives and Areta Kupchyk. FDA will hold a public meeting on September 17, 2010 to seek input on the development of a generic drug user fee program. Currently, FDA does not have the statutory authority to collect user fees for generic drugs. Specifically, FDA seeks comments on: (1) how the … Continue Reading

Generic Drug Settlements, AMP Calculation Provisions Approved by House

On July 1, 2010, the House of Representatives approved an amendment to a supplemental appropriations bill (H.R. 4899) that includes two provisions impacting prescription drugs. First, the House amendment includes a provision to block certain so-called “pay-for-delay” agreements in patent litigation settlements in which a brand-name pharmaceutical company compensates a generic pharmaceutical company for delays … Continue Reading
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