One of your many misleading statements is that the tragedy of the deaths and injuries tied to the outlier NECC revealed “a giant loophole in the regulation of pharmaceutical products: the lack of federal oversight of compounding pharmacies…” Yet, the FDA actually had advance knowledge about problems at NECC as well as the power to take action against the company – but failed to do so. Compounding pharmacists are indeed under “obligation to let FDA inspectors through the door” if they are suspected of dispensing problem products. You actually note, contradicting your premise later in the article, that the FDA “has issued official Warning Letters to seven compounding pharmacies…”
The International Academy of Compounding Pharmacists, representing over 3,600 compounding pharmacists nationwide, supports law and regulatory changes at the federal level that will advance patient safety and ensure that we never have another NECC. But we firmly believe that state boards of pharmacy are appropriately placed and quite qualified to oversee the pharmacist profession, just as state boards have overseen physicians and hospitals for decades. You cite no evidence at all, nor a source, for the statement that “many state pharmacy boards do little to oversee the activity of compounders.” In fact, we have never seen more changes to state pharmacy law than have been enacted over the last year.
One of the FDA’s many jobs is regulating the manufacturing of drugs, which is different than compounding. Compounders use FDA-approved drugs and other safe ingredients to meet the unique health needs of patients for whom off-the-shelf medications have failed. So it is a non sequitur to say that compounded drugs are not “subject to the FDA’s strict manufacturing standards.” Of course they are not – compounded drugs are not “manufactured drugs.” Not in ingredients, and not in quantity.
Compounding is a centuries-old practice, well-regulated, and relied upon by millions of patients and medical providers who seek a personalized solution to their health care needs.
--David G. Miller, R.Ph, EVP & CEO, International Academy of Compounding Pharmacists
How very RIDICULOUS is the Cover Picture of Queen Latifah...looks like maybe was taken when she was a teenager...let's get REAL!
I have been a long time subscriber to More and have always vacillated between whether a read of the mag makes me feel better or worse about myself when it comes to aging. Not having the answer, I just renewed my subscription.
October was the start of the renewed subscription. Big letters on the cover, "Look better with age". I was doing pretty well, pretty happy with my cover-to-cover read - until I got to Ms. Maynard's piece. Huge fan of her writing, let me say. On a long waiting list at my library for "After Her".
But I can't tell you how demoralized I was after reading her piece.
I am 61 and have been told that I have beautiful skin. But my face fell, too, a few years ago. Only the very wealthy like Ms. Maynard, can afford her Restylane in our "eyes, cheeks, forehead and nasolabial folds" so that she can get her face "back", let alone getting it redone every 6 months or so. I don't believe I "earned" my face either, but I have to live with it unlike her.
Perhaps you could have had a companion article, or do one in November, explaining why on earth it costs so much. What are the cosmetic pharmaceutical companies making on these tiny tubes of youth serum? Does it have to be so expensive? Is it so dangerous that their liability insurance requires such high costs? And what does the future hold for the rest of us? Will the costs ever come down? Or will it always only be available to the very rich?
Please do some investigative reporting into this issue. It's cruel to the rest of us.
Meanwhile, I'll lie down tonight to sleep and take a mirror out of my bed stand table to see "sort of" what I used to look like while I'm lying flat and not drooping.
That's my reality, and many others, I'm sure.