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  • Regulatory NewsRegulatory News

    FDA Sets Policy for Granting New Biologic Medicines Extensive Market Exclusivity

    The US Food and Drug Administration (FDA) today released a new draft guidance document intended to explain how biological products approved under Section 351(a) of the Public Health Service Act (PHS Act) are given periods of market exclusivity. Background Under the Patient Protection and Affordable Care Act's (PPACA) Biologics Price Competition and Innovation Act (BPCI), new biological products are eligible for 12 years of market exclusivity during which time the US...
  • Republicans Dig Into FDA for Helping to Promote Obamacare Law

    If you've been paying close attention to the US Food and Drug Administration's (FDA) emails over the last several weeks, you've likely caught onto something unusual: the agency's promotion of something that has almost nothing to do with food, drug, medical devices or other regulated products. Background That thing, as it turns out, is the Patient Protection and Affordable Care Act (PPACA) - "Obamacare," if you like - President Barack Obama's signature health care over...
  • Feature ArticlesFeature Articles

    Sunshine Act Reporting: Research Payments and Requests for Delayed Publication

    On 8 February 2013, the US Centers for Medicare and Medicaid Services (CMS) issued its final rule on the reporting requirements for certain payments and other transfers of value under the Patient Protection and Affordable Care Act ( PPACA ), commonly referred to as the Physician Payment Sunshine Act ( Sunshine Act ). 1 The types of payments, identifying information and classifications for such payments and transfers are outlined in the final rule and require manufac...
  • Orphan Drug Manufacturers Would be Exempt from 'Obamacare' Fees Under New Bill

    A new piece of legislation introduced this week by Rep. Jim Gerlach (R-PA) would clarify that developers of orphan pharmaceutical products are exempted from an annual fee otherwise levied on manufacturers to help fund the government's expansion of national healthcare. Background Orphan drug products have long been exempted from a range of fees otherwise levied on other manufacturers. As defined under the Orphan Drug Act of 1983, orphan drugs are those intended to trea...
  • Long-Awaited Sunshine Act Regulation Released

    • 04 February 2013
    The US Centers for Medicare and Medicaid Services (CMS) have released a long-awaited rule that would require all pharmaceutical, medical device and biopharmaceutical companies to report transfers of value to the US government in the hopes of increasing transparency. Background The rules, the Physician Payment Sunshine Act- better known as the Sunshine Act -are a core part of the 2010 Patient Protection and Affordable Care Act . Championed by Sens. Charles Grass...
  • Senator Calls--Again--for White House to Release Sunshine Act Rules

    A prominent senator is once again calling upon federal officials to pass a long-delayed rule regarding the transparency of payments made by companies to healthcare providers, saying the delays are "unacceptable." Sen. Charles Grassley (R-IA), is the ranking Republican member of the Senate Committee on the Judiciary, and along with former Sen. Herb Kohl (D-WI) sponsored and wrote the Physician Payments Sunshine Act (Sunshine Act), which eventually became part of the 201...
  • Sunshine Act Clears CMS Review, But Final Promulgation Could be Months Off

    • 29 November 2012
    Signs are emerging that a long-awaited landmark regulation governing the transparency of gifts given to medical practitioners by industry has entered its last clearance stage before final promulgation. The rule, Transparency Reports and Reporting of Physician Ownership of Investment Interests , is the direct result of the Patient Protection and Affordable Care Act (PPACA) -colloquially known as Obamacare-the seventh title of which contains the "Physicians Payment Suns...
  • PCORI Board Adopts CER Standards

    The Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI) at its 19 November 2012 meeting in Boston, MA adopted 47  revised methodology standards  that are intended to guide the comparative effectiveness research (CER) funded by PCORI.  The Board also authorized at the meeting the development of three new CER funding announcements: Treatment options for uterine fibroids, the safety and benefits of treatment options for severe asthm...
  • Data Exclusivity for Biologics at Forefront of International Trade Agreement Negotiations

    • 08 October 2012
    A host of biopharmaceutical regulatory issues are said to be at the forefront of trade talks between the US and a group of 11 countries in the Asia-Pacific, potentially complicating both the agreement and the Obama administration's already complicated relationship with the pharmaceutical industry, reports Reuters . The agreement in question is known as the Transpacific Partnership (TPP)-a regional trade policy long under negotiation and periodically subject to trans...
  • RAPS' LatestRAPS' Latest

    Biosimilar Interchangeability Problems Pose Complex Challenge for Regulators

    An emerging class of biological products intended to act as the generic equivalents of earlier, branded products is being threatened globally by an obvious, yet complex set of issues, say two experts consulted by Regulatory Focus . The products-known as biosimilars, follow-on biologics or subsequent entry biologics-are intended to act as interchangeable substitutes for other biological products whose patents have expired and are thus eligible for market competition. Whi...
  • 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...