The FDA has never required study of bio-identical hormones, but they are big business. Is the FDA for sale, like the rest of our government- to the highest bidder?
So generics are fine for everything else but these patients are singled out so as to be responsible for paying for the brand name drug. To take a readily-available and cost effective drug and then limit it to those patients whose insurance companies will pay the inflated price is wrong. Shame on the FDA and the company.
I can't believe this. Everyone, including the congress is trying to bring down the cost of medical care. FDA and Makena makers are doing exactly the opposite. Get ready for many thousands of more premie babies, many more neonatal deaths, many more babies with chronic disabilities. So many mothers will forgo the treatment because they will not be able to afford it, exactly opposite of the WHO goals of reducing preterm births and neonatal mortality/morbidity. I have seen so many pregnant moms not get treated, due to costs, and they are delivering several weeks preterm. Additionally, Doctors are generally scared of medical malpractice. Thanks FDA for scaring the docs even more by making these statements. We have been using 17 P for over 25 years, now suddenly we are been coerced into prescribing the 'brand name' formulation. How do you justify that?
Have seen the same thing happen with everything from colchicine to 4-aminopyridine: take a drug that has been compounded for ages, study it, and astronomically raise the prices to gouge the patients. I had no problem with the effectiveness of compounded progesterone.
Makena was approve based on the data generated using compounded progesterone. Rather than providing a drug at a reasonable rate they have chosen to fleece insurance companies and patients. Ridiculous that they FDA has released this statement. Makena is last ditch option for my patients after compounded and vaginal progesterone.
Makena is a rip-off of the projesterone cmpd that has been around forever. It will be a cold day in El Paso before I write for the agent. Nothing more than price-gouging on the backs of at risk patients. They are trying to make a mountain out of a mole hill with the minimal differences of the compounded agent that has been used for 40 years.