By Palmer Reuther
Stuck between a rock and a hard place, or, in this case, patients and its’ organizational mission, the Food and Drug Administration (FDA) sided with the patients. Late yesterday Dr. Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research, announced that a liquid form of Morphine, currently unapproved by the FDA, will remain on the market in limited supply.
Dr. Douglas Throckmorton
The surprise here for some physicians and patients? Not all drugs on the market are backed by FDA approval. For a list of drugs not approved by the FDA, click here.
Reasoning behind the ruling shed light on the FDA’s more compassionate side as it agreed with hospice and other health care organizations that many terminally ill patients would face significant ”hardship” without access to this powerful pain medication.
The decision is a concession of sorts as just last month the FDA sent a letter to nine pharmaceutical companies, warning them to stop making drugs where the therapeutic benefits remain unproven.
Some many feel that this move by the FDA is more of a PR stunt to gain back waning public trust after a number of premature approvals were forced through its backlogged system, but regardless there are thousands of struggling patients that can rest a little easier today.
April 10th, 2009
By Jackie
Medical device companies rejoiced last week after the FDA released a report claiming faster review processes and approvals of medical devices than ever before. When compared to 2005, the regulation agency decreased its review time by a noteworthy 24 percent, from 438 days in 2005 to 335 days in 2006. According to a recent Reuters article, the agency attributes the significant progress to a 2002 law designed to streamline the FDA review process and establish review time goals.
The regulating body, established in 1937 to protect public health, has maintained a large cohort of critics who claim that the long review process inevitably stifles medical innovation in the U.S. With an inarguably tough job, the FDA is responsible for ensuring the complete safety of all drugs, devices, biological products and more, while simultaneously helping to speed innovations that enable medicines to be safer, more effective and affordable. All in a day’s work…or rather 335 days.
Seems like a catch 22 to me. I think it’s safe to say that most Americans would prefer to wait for the FDA “stamp of approval,” historically synonymous with safety and efficacy, than to risk their own health with questionable medical technologies. That said, we are fortunate to live in a country bursting with cutting-edge advancements that have the potential to diagnose, treat and cure a range of medical conditions and diseases. And I think most patients would agree that access to those technologies can’t come fast enough.
Although the new device review process still averages nearly one year, the question remains: are we really ready to sacrifice safety in the name of medical innovation? Perhaps the responsibility of balancing safety with innovation lies largely in the hands of both Congress and device/drug manufacturers. As the FDA continues to receive the funds and resources it needs to efficiently and effectively complete the review process, we’ll likely continue to see decreases in the turnaround time to bring these often life-saving technologies to hospitals nationwide.
July 2nd, 2008
