The United States Food and Drug Administration Patient Protection and Affordable Care Act (PPACA)

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

Capitol Hill Healthcare Update

After months of debate and partisan wrangling, the House on Wednesday voted 392-26 to pass the “21st Century Cures” bill designed to accelerate the development of new drugs and medical devices as well as increase federal...more

Basics of the BPCIA

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Washington Healthcare Update

1. Congress - Senate - FDA Supports Expanded Authority Over Cosmetics - In an Oct. 5 letter to Senator Dianne Feinstein (D-CA), the Food and Drug Administration (FDA) says its current legal authority over...more

Washington Healthcare Update

This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more

Congressional Hearings Focus on Health Policy Issues - September 2016

A number of recent Congressional hearings have focused on health policy issues, including: ..Senate Health, Education, Labor, and Pensions Committee hearings on laboratory testing in the era of precision medicine, and...more

Washington Healthcare Update

1. Congress - House of Representatives - House Energy and Commerce Committee Republican Leaders Send Letter to HHS OIG Concerning NIH Grant on Traumatic Brain Injury - On Sept. 15, Republican leaders of the...more

OIG Work Plan: A Roadmap to Identify Health Care Compliance Risk

Each year, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) issues a Work Plan that summarizes new and ongoing OIG reviews and areas of focused attention for the coming year and beyond....more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

Washington Healthcare Update

This Week: Double Issue — Congress leaves for seven weeks, Congress sends opioid legislation to the President…More co-ops fail…The Supreme Court rules on Texas Abortion Case and Washington state Pharmacists and Religious...more

6-Month Notice from a Biosimilar Sponsor Always Required — Says Federal Circuit

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On May 6, 2016, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule entitled, “Patient Protection and Affordable Care Act; Amendments to Special...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 21, 2016, CMS issued a proposed rule entitled, “Medicare Program: FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements.” This...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

Washington Healthcare Update

This Week: MedPAC votes on changes in Part D... Senate HELP Committee reports five “Cures” bills... One report shows uninsured number decreasing... Another says, but we still need the safety net. ...more

FDA Approves Second Biosimilar – Inflectra™ – The First Monoclonal Antibody Biosimilar

The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar – Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

FDA Releases Naming Guidance

The Biologic Price Control and Innovation Act (BPCIA), enacted as part of President Obama's Affordable Care Act (better known as "Obamacare," Public Law 111-148), provided for the first time in the U.S. a path for FDA...more

Washington Healthcare Update

This Week: The House of Representatives and the Senate were on recess…but it was not quiet on the health care front! 1. Congress - House of Representatives - House, Senate Democrats Want NIH to Bring Down...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more

Washington Healthcare Update

This Week: The Affordable Care Act turned 6 years old on March 23... Four in ten voters say health care is extremely important when picking a President, according to a Kaiser Family Foundation’s new tracking poll......more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Washington Healthcare Update

This Week: Medicaid program takes financial hits as the House looks for “savers” and acts on a budget... while the Senate sees no reason to do a budget... The Senate focuses on ACA oversight and mental health and opioid abuse...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

Washington Healthcare Update

This Week: Drug pricing remains a focus as CMS rolls out a demonstration project for Part B drugs... The Senate passes The Comprehensive Addiction and Recovery Act (CARA) and Senate Cures legislation moves forward... Senate...more

Dialing in on Health Care Delivery Through Telemedicine

With the implementation of the Affordable Care Act, millions of newly insured patients have entered the health care market, bringing attention to the need for expanded access to services. Meanwhile, rapid advancements in the...more

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