The FDA (Federal Drug Administration) is having a good run of drug approvals this year with 35 new medicines and drugs approved in the last 12 months. This is second only to 2009 when 37 new drugs were approved.

The new products include important innovations for patients with serious diseases, such as :

  • Two new treatments for hepatitis C
  • A drug for late-stage prostate cancer
  • The first new drug for Hodgkin’s lymphoma in 30 years
  • The first new drug for lupus in 50 years

    • Margaret Hamburg, M.D., Commissioner of Food and Drugs said in a statement in the FDA report FY 2011 Innovative Drug Approvals :

    “Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients … We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century.”

    The FDA also provided details of how it implemented expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to increase the number of innovative drug approvals to 35 for the fiscal year (FY) ending Sept. 30, 2011. The approvals maintained standards and drug safety while streamlining the approval process for companies with new drugs.

    The FDA is beating other Government agencies around the world in its approval times, with twenty four out of the thirty five approvals coming through before any other country in the world, including the European Union, and putting the United States at the forefront of innovative medicine and making it easier for pharmaceutical companies to conduct their business and help patients.

    Other approvals include :

    • Two drugs : One for melanoma and one for lung cancer which are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits.
    • Seven new medicines providing major advances in cancer treatment.
    • Ten treatments for rare or “orphan” diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema.

    Showing off its statistics and commitment to supporting the healthcare industry the FDA stated that :

    • Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection.
    • Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness.
    • Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information.
    • Three were approved using “accelerated approval,” a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example: Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program.
    • Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months.

    The PDUFA or The Prescription Drug User Fee Act was established by Congress in 1992 to ensure the FDA had adequate resources to carry out the necessary work to approve new drugs for market in a reasonable and economically efficient timeline. The PDUFA will expire end Sept. 2012.

    Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research said :

    “Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere … As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy.”

    In October 2011, the FDA released a new plan, Driving Biomedical Innovation: Initiatives to Improve Products for Patients, to assist companies engaged in new product development, particularly smaller, entrepreneurial companies.

    Additionally the agency also issued a report this week on drug shortages, expanded its current actions to address the problem, and, at the direction of the President, will broaden early notification of drug shortages and work with the Department of Justice to prevent price gouging.

    Written by Rupert Shepherd