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  • Industry Weighs in on Expedited Products Guidance, Calling for Definitional Clarity

    In June 2013, the US Food and Drug Administration (FDA) released a long-awaited and much-anticipated guidance document on its new breakthrough product designation , and in the process of doing so overhauled much of its existing guidance on so-called "expedited programs" as well. Now one of the pharmaceutical industry's most prominent groups is weighing in on the topic, saying that while the guidance is "critical," extensive changes to definitions are warranted. Backgrou...
  • Pharmaceutical Industry Experts Slam FDA's PDUFA Report, Calling it too Vague to be Useful

    The pharmaceutical and biopharmaceutical industries have long been supportive of the user fee schemes used to fund the US Food and Drug Administration (FDA). Originally passed under the Prescription Drug User Fee Act (PDUFA) in 1992 in response to the delay in approvals in drugs in the US compared to in the EU, the basic fee structure-with some added changes and conditions-has been reauthorized another four times, most recently with the passage of the Food and Drug Adm...
  • PhRMA: FDA Labeling Guidance May Run Afoul of First Amendment, Discounts Value of 'Trade Dress'

    The pharmaceutical industry group Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on the US Food and Drug Administration (FDA) to make several changes to a recent guidance for industry document intended to reduce medication errors by standardizing the way information is displayed on labels and cartons-not just the labeling itself. Background The guidance document, Safety Considerations for Container Labels and Carton Labeling Design to Minimiz...
  • PhRMA to FDA: Data Transparency Proposal ’Concerning,’ Likely Illegal and Unconstitutional

    Earlier this year, the US Food and Drug Administration (FDA) made a quiet but important announcement: It would seek to engender limited clinical trials transparency in the US by releasing de-identified and masked data to select members of the public, but only after soliciting public input to see how the proposal might affect industry. Now the pharmaceutical industry's top trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA) has submitted comments ...
  • PhRMA, EFPIA Call for Clinical Data Transparency, but Principles Fall Short of EMA Proposal

    In an abrupt about-face, two of the most prominent pharmaceutical industry associations, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), have announced a new set of "joint principles" meant to advance clinical data transparency throughout the pharmaceutical industry. Background In recent years, a growing number of voices have been clamoring for greater transparency of cli...
  • BIO, PhRMA Announce Plan to Keep Tabs on PDUFA Progress Through Tracking Database

    The Prescription Drug User Fee Act (PDUFA) is one of the single most important pieces of legislation affecting the life sciences industry, and in particular innovative pharmaceutical and biopharmaceutical companies. It is, at its most basic element, a trade-off between pharmaceutical companies and the US Food and Drug Administration (FDA). In the 1990s, an industry frustrated with the slow pace of drug approvals got together with FDA to float a proposal: If FDA would a...
  • Industry Calls for Changes in Biosimilars Meeting Guidance to Protect Data, Provide Clarity

    In April 2013, the US Food and Drug Administration (FDA) released the fourth in a series of draft guidance documents related to the emerging regulatory framework for biosimilar products, a product classification first passed into law in 2010. Now industry is weighing in on that guidance, saying it needs several major changes in addition to a host of minor clarifications. Background Biosimilars were first identified as a unique regulatory classification under the 2010 P...
  • PhRMA: Industry could Benefit from Less Frequent Reporting of Non-Essential Safety Reports

    A recent guidance document released by the US Food and Drug Administration (FDA) that aims to standardize the process for reporting periodic safety update reports to regulators is winning strong support from the pharmaceutical industry's largest trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), along with a few recommendations to reform the reporting process. Background: ICH The guidance in question, Providing Postmarket Periodic Safety Re...
  • PhRMA, GPhA Call for Revival of Pharmaceutical Track and Trace Measures

    The 2012 passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) was remarkable for both the number of reform provisions contained within it and the overwhelming support it received in the US Congress. But that support was not earned without some hard negotiating, and several prominent but controversial provisions were dropped from the final iterations of the bill. Now some of the industry's most prominent voices are taking to the Washington press...
  • PhRMA, BIO, GSK Call on FDA to Alter eCTD Draft Guidance

    Some of the largest entities in the pharmaceutical industry, including pharmaceutical manufacturer GlaxoSmithKline and industry trade groups BIO and PhRMA, are weighing in on a recent draft guidance published by US regulators, saying minor changes are needed to reflect the clarity of the guidance and its lifespan. Background Their comments reference a 3 January 2013 draft revision of guidance for industry that would require all new drug applications (NDAs), abbreviate...
  • Report: Despite Industry Guidelines, Erectile Dysfunction Ads Viewed by Kids 102 Billion Times

    • 20 February 2013
    "The code is more what you'd call 'guidelines' than actual rules," quipped actor Geoffrey Rush in the 2003 blockbuster, "Pirates of the Caribbean," referring to an oft-broken and morally flexible 'code'. But the same could just as easily be said about the pharmaceutical industry's own code governing direct-to-consumer (DTC) advertising, claims a new study published in the Journal of Health Politics, Policy and Law . Background While pharmaceutical advertising now see...
  • House Releases Previously-unreleased Email Exchanges Between White House, PhRMA

    • 31 May 2012
    A Republican-led investigation into then-secret negotiations between the Obama Administration and the Pharmaceutical Research and Manufacturers of America (PhRMA) has released its preliminary results, consisting of hundreds of pages of internal memoranda and emails between the White House and PhRMA. The investigation has been underway since at least January 2012 when Republican members of the House of Representatives expressed their anger at the Obama Administration appe...