• Regulatory NewsRegulatory News

    Congress Offers New Details on Drug Price Spikes

    Ahead of a Thursday hearing with US Food and Drug Administration (FDA) CDER Director Janet Woodcock sitting beside former Turing CEO Martin Shkreli, the House Oversight Committee has released documents where the former hedge fund manager calls the price hikes of a toxoplasmosis treatment “a very handsome investment.” “We raised the price from $1,700 per bottle to $75,000 … So 5,000 paying bottles at the new price is $375,000,000—almost all of it is profit and I think we ...
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    Researchers See Compounding, Imports as Fix for Pricey Off-Patent Drugs

    Three Johns Hopkins researchers are calling on the US Food and Drug Administration (FDA) to take action on expensive off-patent drugs by permitting bulk compounding and importation of generic formulations of the drug that are approved in other countries. Typically, when a drug goes off-patent and generic versions become available, the price of the drug goes down significantly. Sometimes, due to limited demand or low returns, the market for a particular generic becomes un...
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    Senate Committee Considers Priority Reviews to Stem the Tide of Off-Patent Drug Price Hikes

    Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) hosted a hearing Wednesday to discuss steep price increases for some off-patent drugs and what can be done to ensure patients and hospitals can afford these drugs moving forward. The hearing, which is the first in a series that focuses on companies that, as Collins puts it, “act more like hedge funds than pharmaceutical companies,” follows letters sent to four specific companies – Valeant Pharmaceuticals, Turin...
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    Clinton Urges FDA, FTC to Take Action Against Drug Price Hikes

    In two letters sent Monday, Democratic presidential hopeful Hillary Clinton called on the US Federal Trade Commission (FTC) and US Food and Drug Administration (FDA) to take action against pharmaceutical companies that inflate drug prices and keep generics off the market. In her letter to FDA acting commissioner Stephen Ostroff, Clinton echoes a number of similar calls by politicians such as those by Rep. Elijah Cummings (D-MD) , that Turing Pharmaceuticals' 5,000% pric...