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On May 20, 2014, CMS is hosting another call to discuss the National Partnership to Improve Dementia Care in Nursing Homes, which includes as a goal reducing the use of unnecessary antipsychotic medications in nursing homes. This call will focus on efforts to monitor enforcement rates and track surveyor training completion; the role that activity…

A number of Congressional committees have held hearings recently to address various health policy issues, including the following:

  • The House Energy and Commerce Committee conducted hearings on Medicare Part D drug policy, the role CMS contractors play in management of the Medicare program, and the public health threat of counterfeit drugs;
  • The House Education and

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This post was also written by Jillian W. Riley.

The Food and Drug Administration (FDA) has just announced that it will hold a public hearing March 25 and 26, 2014 to obtain input on the Agency’s current process for reviewing over-the-counter (OTC) drugs. This is a significant advancement in FDA’s long-standing plan to overhaul the OTC drug system. According to the announcement, the Agency’s OTC drug review “needs a critical examination at this juncture to examine whether and how to modernize its processes and regulatory framework.”

Teeing up the importance of the public hearing, Dr. Janet Woodcock, the Director of FDA’s Center for Drug Evaluation and Research (CDER), informed the Wall Street Journal that the Agency was “looking for creative ideas about how to improve the process.”1 According to Dr. Woodcock, “The current system isn’t working well for the public or for us.”  Additional details are available after the jump.Continue Reading FDA to Overhaul an OTC System That “Isn’t Working”

On November 27, 2013, President Obama signed into law H.R. 3204, the “Drug Quality and Security Act” (the “Act”), bipartisan drug distribution security legislation. Among other things, the sweeping measure: clarifies current federal law and regulatory oversight regarding pharmacy compounding; establishes a uniform, national drug tracking and tracing framework; mandates national licensure standards for wholesale distributors and third-party logistics providers; and preempts state product tracing requirements. The following is an overview of the Act and highlights of initial FDA implementation guidance.
Continue Reading Drug Distribution Security Legislation Signed into Law

Congress continues to examine issues associated with enrollment in qualified health plans under Healthcare.gov.  For instance:

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The HHS Office of Disease Prevention and Health Promotion is soliciting public comment on the draft National Action Plan for Adverse Drug Event Prevention. The document focuses on the use of surveillance, prevention, incentives and oversight, and research to reduce adverse drug events. It identifies current federal activity across inpatient and outpatient settings, as…

On July 15, 2013, the Food and Drug Administration (FDA) published in the Federal Register a proposed rule that would amend 21 CFR Part 1 to implement FDA’s detention authority with respect to drugs intended for human or animal use. FDA’s detention authority is authorized by amendments made to the Food, Drug, and Cosmetic Act…

The FDA has recently issued a number of new draft guidance documents that provide insight on a range of issues, including expedited drug review programs, medical device reporting, importation of unapproved drugs for market launch, and safety labeling changes. A brief summary and link to each draft guidance document is provided below:

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The HHS Office of Inspector General (OIG) has issued two recent reports focusing on inappropriate prescribers practices involving drugs paid under the Medicare Part D program. In one report, the OIG concluded that the Medicare Part D program inappropriately paid for drugs (including controlled substances) ordered by individuals who did not have the authority to…

A number of recent Congressional hearings have focused on health policy issues, including the following:

  • The House Energy and Commerce Committee held hearings on bipartisan proposals to redesign the Medicare benefit structure and challenges facing businesses under the ACA. A June 28 hearing will focus on Medicare Part B drug program reforms.
  • House Ways and

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A number of recent Congressional hearings have focused on health policy issues, including the following:

  • The House Energy and Commerce Committee held hearings on bipartisan proposals to redesign the Medicare benefit structure and challenges facing businesses under the ACA. A June 28 hearing will focus on Medicare Part B drug program reforms.
  • House Ways and

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The U.S. House of Representatives has approved by voice vote H.R. 1919, Safeguarding America’s Pharmaceuticals Act of 2013. H.R. 1919 is a bipartisan bill intended to improve drug distribution security and protect against counterfeit pharmaceuticals. According to the bill’s sponsor, Rep. Bob Latta (R-Ohio), the bill would replace an unworkable patchwork of state laws…

Key members of the Senate Health, Education, Labor, and Pensions Committee have released a bipartisan draft legislative proposal intended to improve drug distribution security. The legislation addresses, among other things: lot-level product tracing requirements for “downstream” pharmaceutical supply chain members (drug manufacturers, repackagers, wholesale distributors, and dispensers); a requirement that manufacturers serialize prescription drugs…

The FDA is seeking comments on draft guidance related to clinical trial enrichment: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. The document is designed to provide guidance to industry on enrichment strategies that can be used in clinical trials intended so support effectiveness and safety claims in…

The FDA has released two final guidance documents intended to help sponsors and investigators comply with safety reporting requirements for IND applications and bioavailability (BA) and bioequivalence (BE) studies: Safety Reporting Requirements for INDs and BA/BE Studies, and Safety Reporting Requirements for INDs and BA/BE Studies – Small Entity Compliance Guide. Comments regarding both…