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Diving sheet:
- Comments from the head of a small generic drug maker have become the latest point in a national debate over rising drug prices, prompting public criticism of the head of the Food and Drug Administration, Scott Gottlieb.
- In an interview with the Financial Times, Nostrum Laboratories' CEO, Nirmal Mulye, claimed a "moral requirement" to sell an antibiotic that his company produces at the highest possible price. "It's a capitalist economy and if you can not make money, you can not stay in business, "the Financial Times quoted Mulye as saying.
- Nostrum increased the price of a bottle of nitrofurantoin, used to treat bladder infections, by more than 400%, from $ 474.75 to $ 2,392. This rise, as well as the defense of its CEO, immediately prompted backtracking on Martin Shkreli's now infamous decision to raise the price of a drug called Daraprim of more than 5,000 %.
Dive Insight:
Pharmaceutical companies are outraged at rising prices for their products, and they are not a new phenomenon. Since Martin Shkreli became the face of the drug maker's greed, a succession of companies – both generic and brand – have experienced sharp increases. More recently, President Donald Trump has confronted Pfizer with increases, he has taken about 40 drugs, prompting the drug giant to reverse the trend.
But it is rare for a CEO to publicly justify such actions by claiming a moral obligation. The comments prompted Gottlieb to take Twitter, criticizing the increase in price gouging.
1/2 About @FT history today @ bydavidcrow; There is no moral imperative to consider and take advantage of patients. The FDA will continue to promote competition so that speculators and those who do not care about public health consequences can not benefit patients who need medication
– Scott Gottlieb, M.D. (@SGottliebFDA) September 11, 2018
In The Mulye interview, he said that the price increase of nitrofurantoin was in response to an increase in the cost of a branded version of the drug manufactured by Casper Pharma. A bottle of Casper product, branded Furadantin, lists over $ 2,800, according to Elsevier data quoted by the Financial Times.
PhRMA, the commercial lobby of the industry, has stood out from Mulye's comments.
"Recent comments from CEO of generics maker Nostrum Laboratories are deaf to the tone, especially as patients are increasingly faced with accessibility issues in the marketplace," Stephen Ubl wrote. Director of PhRMA, in a tweet.
Currently, Nostrum does not actively market the product after modifying it following a modification of the FDA's rules on impurities.
But rising prices suggest market dysfunction that may appear in generic categories, even when patent defenses and regulatory exclusives that protect brand-name drugs do not prevent a competitor from entering the market.
If too many providers of a generic drug leave the market, a manufacturer may enjoy limited competition and give free rein to price increases.
Currently, nitrofurantoin is not on the FDA's list of drug shortages, noted Gottlieb in another tweet. A list of approved versions shows that there are four manufacturers of nitrofurantoin in suspension, one of which is the nostrum.
"There are other suppliers of this product and, by its own admission, @FT, the company in question does not actively market their wording, "Gottlieb wrote on Twitter. Their excessive price, detached from the principles of the market, exists only on a list and should remain there in a competitive market. "
Ensuring adequate competition in generic markets is a problem that the FDA is particularly concerned about resolving. Under Gottlieb, the agency has started to list off-patent and non-proprietary drugs without an available generic, in order to quickly approve new versions of copycat.
The FDA has also recently approved the first generic drug under a new designation designed to speed up review for generics of products without competition.
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