• Regulatory NewsRegulatory News

    Researchers See Compounding, Imports as Fix for Pricey Off-Patent Drugs

    Three Johns Hopkins researchers are calling on the US Food and Drug Administration (FDA) to take action on expensive off-patent drugs by permitting bulk compounding and importation of generic formulations of the drug that are approved in other countries. Typically, when a drug goes off-patent and generic versions become available, the price of the drug goes down significantly. Sometimes, due to limited demand or low returns, the market for a particular generic becomes un...
  • Regulatory NewsRegulatory News

    House Panel Calls on GAO to Study FDA’s Approval Pathway for Complex Generics

    Chairman of the House Committee on Energy & Commerce Fred Upton (R-MI), ranking member Frank Pallone (D-NJ) and other representatives on both sides of the aisle are calling on the Government Accountability Office (GAO) to assess the US Food and Drug Administration’s (FDA) approval pathway for generic drugs that have complex active pharmaceutical ingredients (APIs). The request for GAO action follows the introduction of HR 1576 in March, which also calls on GAO to study...
  • Regulatory NewsRegulatory News

    What FDA Can and Can’t Do to Help Lower Rising Drug Prices

    Ask any US Food and Drug Administration (FDA) official how the agency can help lower prescription drug prices and you’re likely to hear the same answer: Drug pricing is not under FDA's purview. And sure enough, FDA doesn’t dip its toe into the pricing bog while deciding whether to approve or reject a new drug, and it also doesn’t negotiate with pharmaceutical companies over how to price drugs. But some FDA regulations do have a direct impact on drug prices, and with so...
  • Regulatory NewsRegulatory News

    Professors Call on Congress to Make More Info Public on Generic Manufacturers

    As discussions over the reauthorization of the Generic Drug User Fee Amendments (GDUFA) continue, two professors from MIT and the University of Chicago are calling on Congress to require the Food and Drug Administration (FDA) to be more transparent about the companies that manufacture generic drugs. The call for more clarity from Rena Conti, assistant professor of Health Policy at The University of Chicago, and Ernst Berndt, a professor of Applied Economics at the MIT Sl...
  • Regulatory NewsRegulatory News

    Senator Calls on FDA to Reduce ANDA Backlog

    As soaring drug prices remain in the national spotlight, the US Food and Drug Administration (FDA) needs to do what it can to reduce its backlog of generic drug applications, Sen. David Vitter (R-LA) said in a letter to FDA Acting Commissioner Stephen Ostroff. With 86% of all US prescriptions filled as generics, the backlog of nearly 3,000 Abbreviated New Drug Applications (ANDAs) at FDA's Office of Generic Drugs (OGD) ultimately constrains market competition and makes d...
  • Regulatory NewsRegulatory News

    FDA to Approve ANDAs on the Basis of Draft Labeling

    The US Food and Drug Administration (FDA) on Monday said via guidance it will approve Abbreviated New Drug Applications (ANDAs) on the basis of draft labeling. The guidance, which FDA is implementing without prior public comment because the agency says it's a "less burdensome policy that is consistent with public health," clarifies that the Office of Generic Drugs (OGD) will no longer require the submission of final printed labeling (FPL) in order to approve an ANDA. Th...
  • Regulatory NewsRegulatory News

    FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi

    A new batch of bioequivalence recommendations issued by the US Food and Drug Administration (FDA) aims to make it easier for generic drug manufacturers to eventually make copies of several popular drugs, including Sovaldi (sofosbuvir), Northera (droxidopa), Xtandi (enzalutamide) and Olysio (simeprevir). Background Bioequivalence recommendations are a critical part of the submission of an Abbreviated New Drug Application (ANDA)—the application generic drug companies subm...
  • Feature ArticlesFeature Articles

    A Lifecycle Approach to ANDA Filings: Lessons Learned

    This article discusses the benefits of implementing a lifecycle approach to ANDA filings to avoid refuse-to-receive notices and deficiencies, ensuring readiness for preapproval inspections. With more than 2,000 Abbreviated New Drug Applications (ANDAs) awaiting review or inspections in 2012, the US Food and Drug Administration (FDA) received additional resources to tackle this backlog with the enactment of the Generic Drug User Fee Amendment (GDUFA ), designed to spee...
  • Regulatory NewsRegulatory News

    Generic Drug Industry Gets More Time to Comment on new FDA Regulatory Policies

    The US Food and Drug Administration (FDA) is allowing more time for industry stakeholders and the public to weigh in on whether new regulations or policies are needed to oversee the generic pharmaceutical industry. Background As Focus has previously reported, FDA issued a Federal Register notice in August 2014 announcing that it planned to hold a meeting to discuss the implementation of the Generic Drug User Fee Act (GDUFA) provisions of the Food and Drug Administr...
  • Regulatory NewsRegulatory News

    What's a ‘High Priority’ Drug? Generic Drug Industry Offers Ideas to FDA

    The generic pharmaceutical sector is calling on the US Food and Drug Administration (FDA) to make changes to a proposed policy that would make it easier for regulators to prioritize the review of some new generic drug products for which there is no previously approved generic. Background In August 2014, FDA released a new policy that proposed a major change to the agency's generic drug review policies. Traditionally, FDA has mostly operated on a first-to-file system in ...
  • Regulatory NewsRegulatory News

    How Should FDA Prioritize the Review of Important New Generic Drugs? Agency Wants to Know

    How should the US Food and Drug Administration (FDA) define the term "first-to-file" when it comes to approving new generic drug products? While the question seems small, at stake is nothing less than potentially billions in savings for consumers and the US government. Background In 2012, Congress pushed through a major piece of legislation to overhaul various aspects of how FDA regulates products. The law, the Food and Drug Administration Safety and Innovation Act (FD...
  • Regulatory NewsRegulatory News

    FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show

    A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking. Background FDA, like any other federal agency, takes actions in response to a wide range of factors. It may, for example, implement a new policy at the explicit direction of ...