Drug price increases have emerged as a core strategy for generic pharmaceutical companies in the recent past. In September last year, Martin Shkreli’s decision to increase the price of Daraprim (Pyrimethamine)
from US $ 13.50 per tablet to US $ 750 overnight, received an angry tweet from Hillary Clinton. “Price gouging like this in the specialty drug market is outrageous,” she had tweeted. Shkreli of Turing Pharmaceuticals wasn’t the only one hiking prices of drugs. ‘Price gouging’ has become a hot topic, and synonymous with the activities of many major pharmaceutical companies. Price increase due
to ownership, not improved scienceValeant
Pharmaceuticals, a stock market darling until
recently, developed a strategy of buying up companies and dramatically
increasing the price of the acquired drugs. In February 2015, Valeant purchased two life-saving heart drugs – Isuprel
and Nitropress.
And the same day, Valeant increased the prices of these drugs by 525 percent and 212 percent
respectively. The increase was not an outcome of improved science but simply a
change of ownership. Similarly, on January 1, 2016, Pfizer raised
prices of more than 100 of its drugs. According to global information
services company Wolters Kluwer the price increase was as much as 20 percent in
the case of some medicines.
Another recent study on US drug prices uncovered that “prices for four of the nation's top 10 drugs increased more than 100 percent since 2011, Reuters found. Six others went up more than 50 percent.” “It’s not funny, Mr. Shkreli. People are dying”Scrutiny on drug price increases and its accounting
practices has made Valeant Pharmaceuticals, which not so long ago was
the biggest company on the Toronto Stock Exchange (TSX), lose 90 per cent
of its market value in less than a year.
“Pharma Bro” Shkreli was arrested
in December for allegedly bilking tens of millions of dollars from his former biotech venture, Retrophin. And
while he smirked
his way through the Senate hearing on drug price increases, he was rebuked by Representative Elijah Cummings. “It’s not funny, Mr. Shkreli. People are dying, and they are getting sicker and sicker,” he told Shkreli, as the latter grinned during the Congressman’s opening statement. The appearance by Shkreli was the highlight of this
congressional hearing, which explored the complicated reality of drug pricing
in the US. Bernie Sanders, a US presidential candidate, has long been protesting “skyrocketing
drug prices” and has also proposed a new bill last year – The Prescription Drug Affordability Act of 2015. FDA’s accelerated review planIn this backdrop, the US Food and Drug Administration (FDA) announced a small regulatory change – it will prioritize review of new applications for generic drugs “that would compete with treatments made by only one company.”The policy mentions that “potential first generic products for which there are no blocking patents or exclusivities on the reference listed drug may receive expedited review”. In an email to Bloomberg, the FDA estimates the change in prioritization could expedite review of as many as 125 generic drug applications. The next ‘price-gouging’ targetsPharmaCompass has
found over 300 different dosage forms of drugs which currently have no patents
and no competition. Click
here to access the compilation (Excel version available) for FREE!Our compilation covers a broad range of products from Pfizer's Premarin, isolated from pregnant mares’ urine, which brings in over
US $ 1 billion in sales to Emcure’s
BICNU (carmustine
or BICNU is an anti-cancer, chemotherapy drug).While Emcure was banned from exporting products to the United
States, due to compliance problems found in their manufacturing operations,
BICNU was exempted since there was no other alternative available in the
market. While an estimated 13 million people in the United States
have latent tuberculosis infection (LTBI), Sanofi’s Priftin
(rifapentine),
launched last year in
a new packaging, still has no generic competition. Click
here to access the compilation (Excel version available) for FREE! Our viewWhile our list provides tremendous opportunities for generic
companies in the short-term, the FDA’s accelerated review program will require
companies to rely on strategies less opportunistic than price-gouging to drive
their future business growth.