• President Signs into Law Budget Bill that Restores FDA's Authority to Spend User Fees

    A new budget resolution passed into law by President Barack Obama on Wednesday will for the first time allow the US Food and Drug Administration (FDA) to spend tens of millions of annual user fees the agency had already been authorized to collect under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, but had been unable to spend under its existing budgetary authority. Background The fees are responsible for funding a significant portion of ...
  • China's SFDA Issues Rule on Imposing Administrative Penalties

    China's State Food and Drug Administration (SFDA) issued a  notice  to the Provinces and Autonomous Regions regarding the application of its Administrative Punishment law, which sets forth the rules for imposing sanctions for violations of the laws and regulations governing drugs and devices.  Local authorities are allowed leeway in deciding the severity of the penalty that is to be imposed on a case-by-case basis, taking into consideration the nature of ...
  • More than $110 Million in FDA User Fees to be Seized Under Sequestration

    The US Food and Drug Administration (FDA) stands to lose more than $300 million in funding and industry-paid user fees under a budget sequestration process scheduled to come into effect in January 2013, according to a new report released by the Office of Management and Budget. The report, " OMB Report Pursuant to the Sequestration Transparency Act (STA) of 2012 ," came in response to legislators' demands that the executive branch release more information regarding th...
  • FDA Could Soon Have Better Information to Plan for Massive Budget Cuts

    Officials at the US Food and Drug Administration (FDA) may soon have a better sense of the impact of an upcoming budget sequestration measure thanks to a new piece of legislation signed into law 7 August by President Barack Obama. The bill, the Sequestration Transparency Act of 2012 , comes as partisan wrangling over the impact of the Budget Control Act of 2011 comes to a head. The act was the culmination of a tense budget standoff between congressional Demo...
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    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...
  • UPDATED: Obama Signs FDA User Fee Bill Into Law

    US President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on 9 July 2012-12 days after the Senate approved the bill and 17 days after the House of Representatives passed the bill. The bill now carries the force of law, though its provisions largely do not come into effect until 1 October 2012. In a statement released by Press Secretary Jay Carney, the White House stated the President had "signed into law" FDASIA , a...
  • 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...
  • Brazil: Anivsa Sets Confidentiality Criteria

    A notice ( Ordinance No. 748-B/2012 ) published by Anvisa on 18 May sets forth the criteria the agency will use for classifying materials as confidential and thus ineligible for release under the Access to Information Act, which recently went into effect.  Examples of what would be classified as non-releasable is information relating to: scientific studies and research projects in progress, intelligence activities, ongoing monitoring, and information treated as con...
  • Brazil: Anivsa Implements Freedom of Information Law

    Greater transparency is an integral part of the reorganization of Brazil's national regulatory agency, Anvisa, and the agency will now release upon written request copies of all documents in its possession, other than those classified as confidential.  The Access to Information Law (Law No. 12.527/2011) establishes as a fundamental principle the constitutional right of public access to public information.  The Law is now in effect according to the ordinance ...
  • Hamburg Calls for New Authority, Strengthened Anti-Counterfeit Laws

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said in a statement she believes existing pharmaceutical anti-counterfeiting laws are grossly inadequate to deter illicit activity, saying counterfeiters deserve "more severe consequences." Hamburg's 10 April statement on FDA Voice , FDA's blog, made clear she believes the Federal Food, Drug and Cosmetic Act (FD&C Act) is outdated. "[The FD&C Act ] was enacted in 1938, long before there was a...
  • Pfizer Executives Sued Under Securities Laws for Allegedly Concealing Clinical Trials Results

    • 02 April 2012
    A federal judge refused to dismiss a case against Pfizer and five former executives for allegedly violating federal securities law by concealing clinical trial results, reports The Courthouse News Service . The class action lawsuit, filed by the Teacher's Retirement System of Louisiana, accuses the company and executives of violating federal securities laws by omitting the results of unfavorable clinical trials from public filing statements made by Pfizer. The defendan...
  • 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...