RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • US Court: Stem Cells may be Regulated as Drugs

    • 27 July 2012
    The US District Court in Washington, DC, has ruled that the US Food and Drug Administration (FDA) may legally regulate stem cell therapies as drug products-an opening salvo in what is likely to be a lengthy court battle between the agency and a company accused of violating federal regulations. The entire case results from a 2008 enforcement activity by FDA in which it found Colorado-based Regenerative Sciences to be in violation of federal law. In a 2008 warning let...
  • Court Orders FDA to Release Thousands of Documents on Surveillance Program

    The US Food and Drug Administration (FDA) has been ordered by a federal judge to release thousands of documents to an attorney representing former employees of the agency who now allege they were the subject of an illegal surveillance program. Judge James Boasberg of the District Court of DC sided with the National Whistleblowers Center (NWC) at the 23 July hearing, and has ordered the agency to turn over more than 4,000 pages of documents related to the case to NWC by...
  • Feature ArticlesFeature Articles

    Orange Book Listings Lesson: An overly broad use code may lead to legal challenges

    The US court system has been busy recently with issues affecting the pharmaceutical industry, including a number of cases involving the Hatch-Waxman Act. On 17 April 2012, the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S marking the first Abbreviated New Drug Application (ANDA) case decided by the high court since the passage of the act in 1984. The Supreme Court has a long history of overturning Federal C...
  • Court: 'Pay-for-Delay' Practice Anticompetitive, Illegal

    In a potentially precedent-setting decision, a federal court has declared that payments made by companies to delay generic competition-also known as pay-for-delay settlements-are anti-competitive and illegal. The lawsuit, filed in the Third Circuit Court of Appeals in California, involved some of the pharmacy and pharmaceutical industry's largest companies, including CVS Pharmacy, Rite Aid, Walgreen, and Merck. The case was also supported by the Federal Trade Commissio...
  • Supreme Court Prepares to Hear Amgen's Challenge to Securities Fraud Lawsuit

    • 12 June 2012
    The Supreme Court of the United States (SCOTUS) said it agreed to hear a challenge from life sciences manufacturer Amgen regarding a lawsuit alleging the company inflated its stock price by misleading investors about the safety of its anemia drugs, Aranesp and Epogen. Amgen is reportedly contesting the class-action nature of the lawsuit, which it says could have the perverse effect of placing severe financial pressures on companies if allowed to stand. "At issue," expla...
  • Judge Calls FDA Decision on Antibiotics 'Arbitrary and Capricious,' Urges Reconsideration

    The US Food and Drug Administration (FDA) has suffered its second setback in as many months after Magistrate Judge Theodore Katz of the District Court of New York ordered the agency to reconsider two petitions which seek to ban the use of antibiotics in animals. FDA had rejected both petitions, respectively submitted to the agency in 1999 and 2005, citing "the time and expense required to evaluate individual drug safety and to hold formal withdrawal proceedings," reports...
  • FDA Appeals Antibiotic Decision, Earning Congresswoman's Ire

    The US Food and Drug Administration (FDA) quietly moved to appeal a ruling by US Magistrate Judge Theodore Katz, who said the agency must either plan to withdraw its approval for most antibiotics used in animal feed or withdraw approval for their non-therapeutic applications. The agency, in conjunction with the US Department of Health and Human Services, filed an appeal with the US Second Circuit Court of Appeals in New York on 21 May. The case was originally filed by ...
  • Senator Plans to Introduce Legislation Reversing Mensing Decision

    • 29 March 2012
    Senator Patrick Leahy (D-VT) moved earlier this week (26-30 March) to introduce legislation to overturn a loophole exposed by a recent Supreme Court case that Leahy claims "threatens the safety of consumers taking generic drugs." In Pliva v. Mensing , the Supreme Court ruled generic pharmaceutical manufacturers are not liable for tort claims based on labeling because federal law requires the drug's label to be identical to the Reference Listed Drug (RLD). "The  Me...
  • What You Need To Know About The Supreme Court Hearing on the Affordable Care Act: Day Three

    • 28 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear arguments today on the Patient Protection and Affordable Care Act's (PPACA) Medicaid expansion provisions and whether the 'individual mandate' is severable from the PPACA . In preparation for those arguments-and the rest of the case- Regulatory Focus has assembled a list of what you need to know about the case, the court, the hearings, the arguments and more. Medicaid: NPR - Supreme Court's Med...
  • After Prometheus Case, SCOTUS Sends Gene Patent Ruling Back to Lower Court

    • 27 March 2012
    The Supreme Court of the United States (SCOTUS) ruled Monday (26 March) to send a case by Myriad Genetics Inc. back to a lower court for review in light of its recent decision, Mayo Collaborative Services v. Prometheus Laboratories , in which the court decided Prometheus's patents on methods to determine the proper dosing for a disease were invalid . In Association for Molecular pathology v. Myriad Genetics , SCOTUS was to consider whether patents held by Myriad on t...
  • What You Need To Know About The Supreme Court Hearing on the Affordable Care Act

    • 27 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear arguments today on the Patient Protection and Affordable Care Act's (PPACA) 'individual mandate' provisions. In preparation for those arguments-and the rest of the case- Regulatory Focus has assembled a list of the essentials of what you need to know about the case, the court, the hearings and more. The Individual Mandate: Reuters - Supreme Court moves to heart of healthcare case The New York...
  • What You Need To Know About Today's Supreme Court Hearing on the Affordable Care Act

    • 26 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear three days of arguments on the Patient Protection and Affordable Care Act (PPACA) starting Monday, 26 March. In preparation for those arguments, Regulatory Focus has assembled a list of everything you need to know about the case, the court, the hearings and more. Case Summary: Washington Post Wonkblog - SCOTUS 101: A Wonkblog guide to health care oral arguments Kaiser Health News - The Health...