FDA Knows Better than Your Doctor?

April 5, 2018

FDA wants to act as your physician and regulate your access to customized medications. Action Alert!

With its new guidance, the FDA is further tightening the screws on pharmacies that produce customized medications for individual patients. The agency is inserting itself into the role of “doctor” by deciding for patients whether there is a “clinical need” for certain medicines to be made at pharmacies. The reason? We believe they want to protect the monopoly of FDA-approved drugs.

In its latest guidance, the FDA is signaling that it will further restrict the medicines that can be made at outsourcing pharmacies by adopting a stringent definition of “clinical need” if there is already an FDA-approved drug for a given condition. This is important for sensitive patient populations, such as autistic children who need their drugs allergen free or in a liquid, as opposed to pill, form.  For example, an FDA-approved drug may contain peanut oil, so it would be inappropriate for patients with peanut allergies, and thus there should be a clinical need to compound that substance in a modified form, without the peanut oil. But if an FDA-sanctioned clinical need cannot be demonstrated according to their new criteria, the variation needed for patients with peanut allergies won’t make it to the preapproved list, and thus won’t be available for those who need it.  

The very idea that the FDA has the expertise to decide every patient’s “clinical need” is ludicrous—these are decisions that should be left up to doctors and their patients. It also undermines consumer choice—if a patient prefers an alternative dosage form out of comfort or convenience, that should be enough, even if there isn’t necessarily an FDA-approved “clinical need.”

This guidance, and the FDA’s entire treatment of customized natural medicines to this point, demonstrate to us that patients and consumers are not the agency’s top priority—rather, it’s protecting Big Pharma’s monopoly over medicine. The guidance admits as much. It says, “compounding a drug product from a bulk drug substance that is a component of an FDA approved drug when there is no clinical need to do so…undermines the drug approval process (emphasis added).”

Since the passage of the Drug Quality and Security Act (DQSA) in 2013, ANH-USA has been closely following the FDA’s implementation of the law—which, by and large, has been a non-stop assault against compounding pharmacies—pharmacies that produce customized medicines for individual patients, such as intravenous vitamin drips and bioidentical hormones, including estriol. We’ve been concerned mostly with “traditional” (503A) pharmacies, but DQSA created a second category called “outsourcing” (503B) pharmacies. Outsourcing pharmacies are generally larger manufacturing facilities and will only make medicines that appear on a pre-approved list by the FDA.

We need to send a message to the FDA that patients will stand up to these attacks against customized medicines.

Action Alert! Write to the FDA and tell them that the bar set for “clinical need” in the new guidance will undercut patient health and consumer choice. Please send your message immediately.

8 responses to “FDA Knows Better than Your Doctor?”

  1. barbarakelly says:

    FDA—-knows crap .

  2. Camille Gilliam says:

    The FDA are a bunch of liars just like the Demorats.

    • MarkTele says:

      Wake up Camille. The FDA is controlled by BIG Pharma. Here is where their “contributions” went in 2017-18;
      Hatch, Orrin G (R-UT)Senate $356,899
      Walden, Greg (R-OR)House $308,000
      Ryan, Paul (R-WI)House $296,045
      Casey, Bob (D-PA)Senate $221,961
      McCarthy, Kevin (R-CA) House $188,050
      https://www.opensecrets.org/industries/indus.php?ind=H04
      … and the biggest liar on the planet used to be a “demorat” but is now a republi-con. So sad.

  3. Rene says:

    These insidious communist leanings, clothed as do good socialism (another form of imprisonment) have spread like a nasty viral contagion. The corruption and obscene dishonest practices and propaganda forced on the public is treasonous plain and simple. The rampant selfish, immoral business as usual for these government goons…FDA, CDC, AMA, NIH….controlling everything in our lives is a disgrace. God Bless America, may she be freed from these crooks. In Jesus name Amen.

    • MarkTele says:

      “communist leanings, clothed as do good socialism” … Jesus F Christ!
      Try unchecked capitalism … follow the money, honey.

      • BikeIce says:

        This is not capitalism………..this is government controlled CRONY capitalism to benefit the FDA and pad it’s profit margins. Think Obozo’s Solyndra fiasco……….only the FDA will never go bankrupt because it has an unlimited amount of Pharma payola coming in via “drug user fees.”
        Free market capitalism would not have any government meddling……..the customer and the supplier would meet a need and determine a price without interference. The FDA would so what it’s supposed to do………..test the drugs for safety and efficacy then get out of the way after “FDA approval.” Ditto third party insurance companies who are involved in price fixing with Pharma.

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