The Food and Drug Administration (FDA) is under continuous pressure from the mass media and the law profession to test new drugs more stringently and give its approval only to very safe and effective drugs, with very clear and specific labeling. Now, for a change, the FDA has come under pressure from the medical profession to be less stringent in this case.
A while back, the FDA pulled 14 painkillers from the market because they had not received proper government approval. They had been used effectively for decades, but the FDA decided that they might be of poor quality, unsafe, or ineffective. People in severe pain were told they could use other painkillers which had FDA approval.
One Painkiller Restored to the Market
On April 9, the FDA conceded that one of the 14 drugs could be used. It is a liquid form of morphine given to people at the end of life who are dying at home or in a hospice. It is thought that about two million Americans are given this drug each year. Caregivers place a few drops in the patient’s mouth and it gives quick pain relief. It is particularly useful for patients who have difficulty with swallowing larger amounts of fluid or who cannot be given medication shots.
Doctors and nurses who work in pain relief and hospice care have welcomed this FDA reversal enthusiastically. There is no alternative to this particular drug, as opiate painkillers are not plentifully available. Without it, families could be calling 9-1-1 and having their dying loved ones rushed to an emergency room for shots.
Discussions Planned with FDA
Dr. Porter Storey, the executive vice president of the American Academy of Hospice and Palliative Medicine called this FDA reversal “a really important step in the right direction”, adding that it shows “an amazing level of responsiveness we’re not used to seeing in our government officials.” He is still concerned about the other 13 drugs being withdrawn, which contain morphine, oxycodone or hydromorphone.
Dr. Douglas Throckmorton of the FDA has told reporters that the FDA is open to more information on the 13 drugs still withheld and would conduct discussions with experts working in hospice and palliative care. But for the moment, this withdrawal will stand.
Proper testing and evaluation of powerful drugs is of course crucial for public safety. When an approved drug is found to be defective it is entirely necessary and appropriate to take the FDA to task. It is also reassuring to know that FDA officials will listen to medical professionals and possibly heed their advice, especially in regard to elderly people dying in pain.
If you have been harmed by a defective drug and would like to know more about your legal position and options, please call or email our defective drug lawyers at Long & Long today, for a free case evaluation.