Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 04 November 2015 | By Zachary Brennan
The fire stoked by rising drug prices is starting to spread through government, particularly as Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) on Wednesday announced a bipartisan Senate investigation into pharmaceutical price gouging, with letters to four companies.
The letters sent Wednesday follow on the heels of HHS announcing Tuesday that it would dig into drug pricing at an invitation-only forum on 20 November. The forum will feature five panel sessions on the impact of rising drug prices, what drug classes contribute the most to higher prices and what types of innovative purchasing strategies might be employed to stem the rise.
Similarly, top House Democrats, including Reps. Elijah Cummings (D-MD), Rosa DeLauro (D-CT) and Jan Schakowsky (D-IL) launched an affordable drug pricing task force, citing a recent report that 77% of Americans identified rising drug prices as their primary health concern.
Cummings said at a press conference Wednesday that the issue has been elevated by the Democratic presidential front-runners Bernie Sanders and Hillary Clinton’s proposals to lower drug prices, noting that he’s even called on Attorney General Loretta Lynch to investigate some of the hikes. Democrats are also criticizing House Oversight Committee Chairman Jason Chaffetz (R-Utah) for refusing to hold hearings to investigate the pricing issues after calling for such a hearing in late September.
The political pressure comes as the recently-passed budget deal will force generic drugmakers to pay higher rebates if the price of the generic outpaces inflation.
In a letter to Valeant Pharmaceuticals, which has been blasted by the media in recent months for its price hikes and relationships with specialty pharmacies, Collins and McCaskill note that the US Senate Special Committee on Aging is opening an investigation into the company’s pricing of off-patent drugs.
More specifically, the senators request more information about the company’s acquisition of the rights to sell two drugs to treat cardiac arrest – Isuprel and Nitropress – and another drug to treat Wilson’s disease, known as Cuprimine. The price of Nitropress rose 625% the same day Valeant purchased its rights, while Isuprel rose 820% and Cuprimine rose 2,949%.
The senators seek from Valeant a host of documents and analyses linked to the drugs and their prices, including more information on how much these drugs cost in other countries, how Valeant came to its decision to price the drugs the way it did and whether or not it spoke with the US Food and Drug Administration about the drugs.
In a separate letter to the now-infamous Turing Pharmaceuticals, the Senate committee seeks more information on the company’s decision to hike the price of its toxoplasmosis drug Daraprim from $13.50 per tablet to $750. The committee also requested a lot of the same documents and analyses that it requested from Valeant.
Turing CEO Martin Shkreli met with some of his critics in Washington on Tuesday, and according to a New York Times report from Wednesday, he agreed to reduce the price of the drug by about 10%, though that may not be enough of a drop to appease some of his critics.
At a press conference on Wednesday, the House drug pricing task force posted a picture of Shkreli and a quote from him on how he grieves every time a drug goes generic. Clinton also previously sent a letter to the Federal Trade Commission over Turing.
The committee also sent a letter to Shkreli’s old company – Retrophin – which licensed the rights to a kidney disease drug known as Thiola and hiked its price from $1.50 per tablet to $30. Similar to the other letters, a host of documents and analyses were requested.
The final letter was sent to little-known, Georgia-based Rodelis Therapeutics, which acquired a drug to treat multidrug-resistant tuberculosis, hiked the price of the drug substantially but eventually returned the rights of it to the Chao Center for Industrial Pharmacy and Contract Manufacturing, which is where the drug was acquired.
The committee seeks more information on why the company hiked the price for 30 pills of Seromycin from $500 to $10,800, as well as why it decided to return the rights to the drug to its previous owner.
Letter to Valeant
Letter to Turing
Letter to Retrophin
Letter to Rodelis
HHS Pharmaceutical Pricing Forum
Tags: Elijah Cummings, Valeant Pharmaceuticals, drug prices, Senate investigation