How do new drugs obtain FDA approval?
This week we are examining the process the FDA calls Fast Tracking of drugs. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
The purpose of fast tracking is to get important new drugs to the patient earlier. The FDA acts to check the impact on such factors as survival, day to day functioning, or the likelihood that the condition if left untreated, will progress from less severe to more severe
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than ones that are available.
If there are available therapies a fast track drug must show some advantage over existing ones:
- Superior effectiveness
- Avoiding serious side effects of existing ones
- Improving the diagnosis of serious conditions where early diagnosis results in improved outcomes
- Decreasing clinically significant toxicity of available therapies which often leads to discontinuation of treatment
- The thought is that by fast tracking, the FDA will have the ability to address emerging public health needs. A record high 43 drugs came through in 2018. This represents 73% of new drugs approved by the FDA in 018.
The Wall Street Journal says the FDA generally fast tracks drugs intended to treat conditions that are debilitating or deadly and have few or no other treatments.
FDA granted fast tracking to at least 60% of the new drugs approved in each of the last five years. 10 years ago, the FDA only approved 10 new drugs by this method.
There are concerns about public safety because there are trade- offs. If they approve a drug and eventually they discover some negative side effects or issues the drugs will already be on the market……..
But the data tends to be positive in favor of fast tracking:
19% of the 42 cancer drugs significantly extended patient lives as well as 26% of the 34 expedited cancer drugs approved from 2011-2014.
Still, fast tracking is somewhat controversial because of political issues and questions surrounding how these decisions are made.
Viagra was fast tracked because there was a social concern about men needing to have a satisfying sex life. It was approved within six months. A similar drug for women took six years, seemingly because society does not see the value of being concerned about sexual satisfaction among women.
Generally, society sees that if you are a man struggling to have a satisfying sex life it deserves not only a solution but one you don’t have to pay for. Almost all insurance companies cover this cost for men. Women’s rights to sexual desire, satisfaction, and birth control are more complicated in our history and are only recently getting serious attention.
Now there is a disorder called HSDD. Hypoactive sexual desire disorder. A medical condition causing low libido that affects one in ten women.
HSDD has two key hallmarks: decreased sex drive and libido, coupled with feelings of distress because of the decreased sex drive. (not everyone is worried about this when they lose it)
Psychological factors are considered when treating HSDD and there are also biological imbalances that cause it and nonsexual diseases like arthritis, there are certain medications that can lower sex drive, fatigue or hormonal shifts during menopause and pregnancy can as well.
There has been a societal narrative that reduced everything that went wrong in the bedroom with women to psychology and everything that went wrong in the bedroom with men to biology. We believe that this is changing, but ever so slowly.
There are two new drugs for women to treat HSDD:
Ayddi and Vyleesi
Vyleesi is an injectable medication meant to be taken within six hours before a person intends to have sex, and works in about 45 minutes lasting about 16 hours.
Ayddi is a pill taken once a day but it can take at least two weeks to start working. It was originally developed as an antidepressant, and you cannot drink alcohol while taking it.
With vylessi nausea is a common side effect.
Low testosterone is an issue with sex drive for women as well.
If you don’t want to take a prescription drug or can’t afford it or your insurance does not cover it, you may want to take a supplement.
Herbs like Maca and Shatavari can help boost libido in both pre and postmenopausal women but results vary and there are consistency and standardization issues with herbals.
On balance, we feel that it is a good thing that the FDA is working to increase the approval process for new drugs. They are finally starting to use the European model more regularly. Hopefully this will result in better health care for the American people.
This Health cast was written and presented by Dr. Kathy Maupin, M.D., Bio-identical Hormone Replacement Expert and Author, with Brett Newcomb, MA., LPC., Family Counselor, Presenter and Author. www.BioBalanceHealth.com.
