Regions

US FDA to check Martin Shkreli's type of strategies to spiraling up drug prices

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March 15
4:14 AM 2016

The US Food and Drug Administration (US FDA) is very keen on approvals to generic drugs. US FDA is reviewing new applications for generic drugs to ensure that there wouldn't be any such strategies like Martin Shkreli played to jack up drug prices. 

Approval from the FDA will enable company to make generic drug, an old and patent-expired medicine for treatments. It'll not have any competition for the company that gets FDA approval on patent-expired generic drug. Taking undue advantage of this system, Martin Shkreli, former Chief Executive Officer at Turing Pharmaceuticals AG, jacked up price of a pill from $13.50 to $750.

Martin Shkreli, who's facing securities fraud charges, acquired Daraprim, a decades-old anti-parasitic treatment drug. He became notorious for manipulative price strategies. He was the CEO of Turing Pharmaceuticals AG until 2015. FDI is planning to prioritize the review process of 125 new applications for generic drugs, as reported by Bloomberg.

Sandy Walsh, spokeswoman at US FDA, said in an e-mail that the agency already prioritized review for generics that would be the first to compete with a brand name product. 

Turing Pharmaceuticals AG was the only company with FDA approval on Daraprim generic medicine. Shkreli used this advantage to artificially jack up the price. He further defended his strategy saying it was a game by rules. He further insisted that price should have gone up much more than what he did. 

Dealbreaker further adds that Martin Shkreli's former company to get bankruptcy loan is still pending. Shkreli sometime back acquired a struggling pharma company KaloBios. The recent fraud charges forced him to step down as CEO of KaloBios. Shkreli has been called by the Congress to testify for the price jacking up. Now financing outlined in papers filed with US Bankruptcy Court in Wilmington, may help fund a deal that Shkreli commenced. KaloBios is now planning to close this deal.   

Martin Shkreli is also facing securities fraud charges pertaining to separate former company and other hedge funds he used to run. Shkreli said he was innocent in all these transactions and pleaded not guilty. After Shkreli was arrested, Turing Pharmaceuticals AG has fired him from his CEO position. Neither Turing Pharma nor Shkreli provided details on the latest developments.

An Abbreviated New Drug Application (ANDA) data reveals the status of new applications for generic drugs submitted to US FDA's Center for Drug Evaluation and Research Office of Generic Drugs provides for review and approval of a generic drug. Applications for generic drugs are termed abbreviated as they don't require preclinical (animal) clinical (human) data assuring safety and effectiveness, according to FDA.

Generally, old drugs after patent expiration may have ceased to exist as companies originally invented them have stopped production of those medicines. These are called generic medicines. Original companies may sell the rights to another pharma company also. It also takes months or years to get new version approved by US FDA. Whoever holds right will have opportunity to manipulate pricing mechanism. This leaves a single version to monopolize the market.

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