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Manufacture Business Practice, Standards & Regulation, Quality & Compliance, Trends & Forecasts

Business-in-Brief

This month sees some interesting developments in the US Department of Justice’s (DOJ’s) investigation into price fixing and collusion among generic pharma companies, as well as a recent report into antibiotic pollution in the pharma industry.

Investigations

Generic pharma companies could face charges of price collusion following a two-year DOJ investigation. $8.5 billion in market value was wiped off generic company shares on Thursday, November 3, after it was revealed the DOJ are preparing criminal charges after their longstanding investigation into suspected price collusion. Bloomberg broke the story, quoting “people familiar to the matter,” who said that the investigation “now spans more than a dozen companies and about two dozen drugs.”

Bloomberg, “U.S. charges in generic-drug probe to be filed by year-end”, (2016). Available at: http://bloom.bg/2fNj1p5 Last accessed November 22, 2016.

US lawmakers, Bernie Sanders and Elijah Cummings, have called for the DOJ to investigate possible collusion between Eli Lilly, Novo Nordisk and Sanofi over insulin prices. In a letter to the regulators, they point out that the drugmakers have often increased the price of insulin in unison.

Congress of the US, (2016). Available at: freepdfhosting.com/81a7a67226.pdf Last accessed: November 22, 2016.

Elections

Californians voted against the “California Drug Price Relief Act,” by a margin of 8 points – 54 percent for, and 46 percent against. The proposition would have prohibited state health programs from purchasing prescription drugs that cost more than the lowest price paid by the Department of Veterans Affairs. Pharma spent over $100 million supporting the successful “no” campaign.

Reuters, “California voters turn down drug pricing initiative”, (2016). Available at: http://reut.rs/2ekwCok Last accessed November 22, 2016.

Pharma stocks were among the few risers following the result of the US Presidential election. Shares in AstraZeneca and GlaxoSmithKline rallied by more than 2 percent, while Shire was up more than 8 percent.

The Telegraph, “Dow Jones ends 1.4pc up after markets endure rocky day of trading following Trump triumph”, (2016). Available at: http://www.telegraph.co.uk/business/2016/11/09/peso-dollar-and-stocks-sinking-while-gold-rises-as-markets-watch/ Last accessed November 22, 2016.

Manufacturing

A new report by Changing Markets has found evidence supporting the claim that pollution from pharma plants is contributing to antibiotic resistance. Researchers sampled water from three factories in India and found evidence of drug-resistant bacteria.

Changing Markets, “Superbugs in the supply chain”, (2016). Available at: http://epha.org/wp-content/uploads/2016/10/Superbugsinthesupplychain_CMreport.pdf. Last accessed November 22, 2016.

Merck KGaA has opened a new $188-million manufacturing plant in China and will be investing $88 million in a Life Science Center located near the Nantong site. The plant will produce drugs for China’s Essential Drug list to meet the growing demand for medicines in the country.

Merck, “Merck invests €250 million in production value chain in china”, (2016). Available at: http://news.merck.de/N/0/64996B2A1C272FE6C1258060003A2895/$File/Nantong_Eng.pdf Last accessed November 22, 2016.

Regulation

The Indian Government is set to disband its National Pharmaceutical Pricing Authority. The move will stop the procedure by which drugs labeled as “essential medicines” are automatically subjected to price controls.

India Times, “Government may disband National Pharmaceutical Pricing Authority”, (2016).
http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/government-may-disband-national-pharmaceutical-pricing-authority/articleshow/55214006.cms

Mylan says it is working to finalize a settlement with the US government regarding Medicaid reimbursements of the EpiPen. West Virginia Attorney General Patrick Morrisey has urged federal and state officials to reject the settlement offer.

CNBC, “West Virginia AG blasts 'irresponsible, sweetheart' EpiPen settlement with Mylan”, (2016). Available at: http://cnb.cx/2erznT4. Last accessed November 22, 2016.

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About the Author
James Strachan

Over the course of my Biomedical Sciences degree it dawned on me that my goal of becoming a scientist didn’t quite mesh with my lack of affinity for lab work. Thinking on my decision to pursue biology rather than English at age 15 – despite an aptitude for the latter – I realized that science writing was a way to combine what I loved with what I was good at.

 

From there I set out to gather as much freelancing experience as I could, spending 2 years developing scientific content for International Innovation, before completing an MSc in Science Communication. After gaining invaluable experience in supporting the communications efforts of CERN and IN-PART, I joined Texere – where I am focused on producing consistently engaging, cutting-edge and innovative content for our specialist audiences around the world.

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