I can finally write that the FDA has done something right! Albeit, with no fanfare, the FDA changed regulations to prevent another Martin Shkreli from jacking up drug prices unreasonably.
I can finally write that the FDA has done something right! Albeit, with no fanfare, the FDA changed regulations to prevent another Martin Shkreli from jacking up drug prices unreasonably. The change now allows for a fast-track review of generic versions of higher priced drugs that are no longer patent protected. In other words, the days of Shkreli and his Big Pharma Bros financially raping the patient population because they’re the sole producers of a needed medication are over!
The rule change, being referred to as a “regulatory tweak” allows a fast-track review process of generic drugs that could replace off-patent monopolized drugs. This keeps Big Pharma from monopolizing off-patent medications and raising prices through the roof as the generics can be approved in only months, instead of years.
Sandy Walsh, FDA spokesperson, sent an e-mail to Bloomberg stating that the FDA believes up to 125 generic drug applications will soon be fast-tracked due to the “regulatory tweak.” That’s one heck of a powerful “tweak,” in my opinion!
The rule change is a result of nationwide anger at price-gouging from Big Pharma, specifically
Valeant Pharmaceuticals & Shkreli’s former company Turing Pharmaceuticals. Both Valeant and Turing, plus the much-hated Shkreli, were called to testify before the House and Senate over the ridiculous and heartless price increases of medications they produced.
Valeant’s Isuprel, an emergency drug used to prevent fatally slow heart rates, saw its price increased to $2,700 from $50. Certain hospitals pulled the drug from medical carts used in life-or-death situations and put it under lock and key.
We all remember the price increase Shkreli instituted for Daraprim last year. The former Turing CEO jacked the per pill price from $13.50 to $750. Daraprim is usually given to those with immune system challenges (HIV/AIDS/chemotherapy patients), as well as babies and pregnant women. It is the most effective treatment for toxoplasmosis, a parasitic infection. Thanks to Shkreli’s price increase, some patient co-pays were as much as $16,000 for one prescription.
While Shkreli was CEO of Turing last year, the company raised the prices of an anti-parasitic medication called Daraprim from $13.50 a pill to $750. The medication is often prescribed to people with HIV/AIDS, pregnant women, and babies. With the price increase, some of those patients received $16,000 co-pays for a single prescription. Perhaps the new FDA regulations will fast-track Imprimis Pharmaceuticals’ generic version of Daraprim! This pharmaceutical company with a heart stated its goal as selling generic Daraprim for $1 per pill!
These price increases were made possible due to the fact that Valeant and Turing were the only companies making these life-saving medications. Due to the fact that these drugs are for relatively small patient populations, not many rival Big Pharma companies felt compelled to compete.
The Congressional hearing revealed that top executives from both Valeant and Turing made millions of dollars off of the increased prices. Documents subpoenaed by investigators show that Turing threw lavish parties and handed out six-figure bonuses.