Another Pharma Company Recaptures a Generic Medication

Applehu Akbar writes: Daraprim, currently used as a niche AIDS medication, was developed and patented by Glaxo (now GlaxoSmithKlein) decades ago. Though Glaxo's patent has long since expired, a startup called Turing Pharmaceuticals has been the latest pharma company to 'recapture' a generic by using legal trickery to gain exclusive rights to sell it in the US. Though Turing has just marketing rights, not a patent, on Daraprim, it takes advantage of pharma-pushed laws that forbid Americans from shopping around on the world market for prescriptions. Not long ago, Google was fined half a billion dollars by the FDA for allowing perfectly legal Canadian pharmacies to advertise on its site. So now that Turing has a lock on Daraprim, it has raised the price from $13.50 a pill to $750. In 2009 another small pharma company inveigled an exclusive on the longstanding generic gout medication colchicine from the FDA, effectively rebranding the unmodified generic so they could raise its price by a similar percentage.

Comments

Shop elsewhere if you need this drug

[Calibax]

Daraprim (generic name Pyrimethamine) is also used a alternative treatment for maleria where quinine cannot be used, although resistance is now prevalent worldwide. The manufacturing cost is roughly $1 per 25 mg tablet, so even the old price of $13.50 per tablet is a very substantial markup. A typical course of treatment requires around 90 to 120 tablets.

Anyone in the USA needing this drug should fly to the UK where it is still manufactured by GKN and sold for the equivalent of $70 for 90 tablets. Those same 90 tablets would cost $67,500 at the new price in the USA, so the saving would be substantial even allowing for air fare, hotel, etc.

Some enterprising company willing to spend the money to get approval to import the drug from the UK would put this startup out of business. Hopefully.

Re:Shop elsewhere if you need this drug

[Cyberax]

The problem is, you CAN NOT get an approval for an alternative generic. This shitty fucktard invoked an FDA clause allowing this company to use "closed distribution". I.e. this company can pick and choose to which customers it sells the drug in exchange for discounted pricing.

Why does it matter? - To market a generic drug you need to show that it's equivalent to an existing drug. And Turing can block any such clinical study - a classic Catch-22. This loophole should be fixed, but given the dysfunctional state of the Congress any bill fixing this will probably be encumbered with a prohibition on abortions and more NSA spying.

Re:Shop elsewhere if you need this drug

[slew]

AFAIK, the situation is like this. As part of the 2007 update to the Food and Drug Administration Act added the authority for the FDA to require drug manufacturers to implement a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biological product outweigh its risks. The theory was that some drugs might have serious enough side effects or complicated treatment plans that the FDA should require drug manufactures to make sure patients weren't harmed needlessly by taking these drugs in a way not supported by safety trials (aka elements to assure safe use or ETASU).

As an example, they could restrict wholesalers to sell the drug only to physicians or patients who attended training seminars, or only allow use for certain purposes and time-limit quantities to prevent certain side effects, make sure medicine is stored correctly and destroyed when expired, and they could require patients to be monitored for certain specific serious side effects, not allow the drug to be administer to otherwise healthy people etc... Seemed like a good idea at the time....

The unintended side effect of this is that Pharma companies have been crafting REMS to make it nearly impossible for generic manufacturers to obtain sufficient quantities of approved drugs for the required safety and equivalence trials. For example, a part of the ETASU might be that all patients must attend a company training seminar, or not allow the drug to be used on healthy people, but if you are doing a blind trial, that won't work.

To make the situation worse, even if the FDA didn't require REMS for a particular drug, the Pharma companies decided to "voluntarily" implement similar restrictions for their drugs on the wholesalers.

Wholesalers that don't comply with the Pharma's ETASUs would be violating both FDA rules and probably licensing restrictions and subject them to direct liability and thus will generally not sell product directly to these generic manufacturers. The only option remaining for generic manufacturers would be to purchase the product directly from the brand-name manufacturer. Under current law they are not required to sell drugs directly to their competitors and under strict interpretation of the FDA act, if a drug has a specific REMS, it is likely not technically legal.

Also even if the generic manufacturer decided to buy some of the drug on the "grey-market", they won't satisfy the requirements of the ANDA (abbreviated new drug application) which would require the same version available in the US market for demonstrating bio-equivalence.

FWIW, in 2012 there was an effort to amend the FDA act to allow the medical trials to bulk purchase of brand-name drugs at market prices and exempt REMS requirements, but it failed due to heavy lobbying...

Re:Shop elsewhere if you need this drug

[Tony Isaac]

You are not allowed to sell a generic equivalent unless you can prove it is as effective as the nongeneric version. In order to prove it is as effective as the nongeneric version, you need to do trials that compare it to the nongeneric version.

This is not correct. From the FDA:

The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.

The generic drug manufacturer needs only to prove that their version is equivalent to the original (details also spelled out at the above link.)