• Regulatory NewsRegulatory News

    New Bill Would Speed FDA Review of OTC Contraceptives

    Editor's note: This article has been updated to clarify that the Oregon bill allows pharmacists to prescribe certain contraceptive drugs to patients. A new House bill, sponsored by Rep. Mia Love (R-UT), would speed the review of contraceptive drugs by the US Food and Drug Administration (FDA), and includes measures to make the drugs available over-the-counter for adult women. The bill, known as the Over-The-Counter Contraceptives Act , would compel FDA to grant suppl...
  • Regulatory NewsRegulatory News

    What's in Store for the Medical Device Tax?

    Last month, the US House of Representatives passed a bill that would repeal the medical device tax levied under the Affordable Care Act ( ACA ). Now, the Senate Joint Economic Committee (JEC) has released a report critical of the tax, calling the tax "onerous" and "poorly conceived." Background The medical device tax has been controversial since before ACA was signed in 2010. Under ACA , a manufacturer or importer of a medical device is subject to an excise tax of...
  • CDRH Cedes Regulatory Authority for Certain Wound Care Products to CBER

    If you're the sponsor of a wound care product, you may soon be dealing with a new set of regulatory staff at the US Food and Drug Administration (FDA), the agency announced in the Federal Register on Tuesday. The 13 August 2013 announcement explains that FDA is "transferring oversight responsibilities for certain wound care products" from the Center for Devices and Radiological Health (CDRH), where some new reside, to the Center for Biologics Evaluation and Research (C...
  • FDA Cracks Down on Spurious Marketing Claims for Cosmetic Products

    The US Food and Drug Administration (FDA) is increasingly cracking down on the marketing claims used by some cosmetic companies, firing off at least three warning letters in as many weeks regarding allegedly unfounded claims used to market various products. In an opening salvo, released in the form of an 11 September warning letter , FDA alleged French cosmetic giant L'Oreal's US subsidiary, Lancôme USA, was using a number of improper marketing claims that caused ...
  • Trade Associations Want Time Before Sunshine Act Begins

    • 29 August 2012
    The Centers for Medicare and Medicaid Services (CMS) is prepared to publish a final rule for the Physicians Payments Sunshine Act , but some trade associations are asking for more time before implementation of that rule. According to CMIO , four life science trade associations sent a letter to CMS, insisting sufficient notice be given before collection of data begins. They are asking for 180-day grace period after the final rule is released before reporting is required...
  • Supreme Court Upholds Majority of Affordable Care Act in Historic Decision

    • 28 June 2012
    In a historic decision, the Supreme Court has upheld the vast majority of the Patient Protection and Affordable Care Act (PPACA), ruling in a tightly-contest 5-4 decision that the law-and its individual mandate-could stand with some minor alterations. Chief Justice John Roberts, appointed by President George W. Bush, joined with Justices Ginsberg, Sotomayor, Kagan and Breyer to decide in favor of the law. One of the law's most contested provisions, the individual mand...
  • How Will the Supreme Court's Ruling Affect Pharmaceutical and Medical Device Companies?

    • 27 June 2012
    On 28 June 2012, the Supreme Court of the United States (SCOTUS) is expected to pass down several judgments deciding the fate of the Patient Protection and Affordable Care Act (PPACA)- a sprawling piece of legislation that has inspired deep division among the American public. At issue before the court is a series of court cases all asking SCOTUS a similar question: Is PPACA constitutional? As indicated by the questions asked by the justices during the cases' respecti...
  • Castellani Says PhRMA Looking to Uphold Affordable Care Act to Protect Regulatory Pathway

    • 13 April 2012
    The Pharmaceutical Research and Manufacturers of America was an early-and controversial - supporter of the Patient Protection and Affordable Care Act (PPACA) when the legislation was being formulated. Now under the tutelage of President John Castellani, the group says it is looking to keep the legislation in place, reports Market Watch . The loss of a regulatory pathway for approving biosimilar products, said Castellani, would be a disastrous setback. Likewise a num...
  • Deadline for Mandatory Submission of Drug Sample Information to FDA Closes Soon

    The US Food and Drug Administration (FDA) released updates this week (26 March) on submitting information required under the Patient Protection and Affordable Care Act (PPACA) . Under the law, pharmaceutical companies are required to submit certain drug sample information to FDA before 1 April 2012 and every year thereafter. Under the PPACA's Section 6004, " Prescription Drug Sample Transparency ," manufacturers must submit: the identity and quantity of drug samples...
  • NICE Announces More Than 120 New Quality Standards

    The National Institute for Health and Clinical Excellence (NICE), the UK's care-rationing body, announced 22 March it is developing more than 120 new quality standards, dramatically increasing the number of standards in development. NICE currently has 15 published quality standards, and already has another 20 in development in addition to the 123 new proposed standards. The new standards will cover a wide range of diseases, conditions and habits, including pneumonia, mul...