Compliance and Safety Snags Dominate Headlines, Systemic Data Manipulation & Integrity

PharmaCompass’ Weekly Recap: Compliance and Safety snags dominate deadlines

Beginning this week, PharmaCompass introduces this new column on the week’s headlines in the world of pharmaceuticals. Get the buzz on what to expect in the days to come. Though we are only a few weeks into 2016, we notice that compliance and safety problems are continuing to dominate headlines.

Mylan finally acquires Meda for US $ 7.2 billion

The week’s biggest news has been the acquisition of Swedish-firm Meda AB by Pennsylvania-headquartered Mylan NV for about US $ 7.2billion. Meda will strengthen Mylan’s specialty drug products and European operations. The acquisition also marks one of the highest premiums ever paid in a pharma deal worth US $ 5 billion of more. The deal comes after two offers made by Mylan to acquire Meda in 2014 were rejected by the latter. Last year, Mylan also failed in its attempt to acquire Perrigo Co, a manufacturer of over-the-counter (OTC) drugs.

“Systemic data manipulation” uncovered by FDA at Ipca

Three Ipca sites have been on FDA’s import alert list for almost a year. Last week, FDA’s warning letter to India’s Ipca Laboratories became available for review. The FDA inspections were done in 2014. The most striking aspect of the letter is Ipca’s “systemic data manipulation”. The letter says data manipulation practices are commonplace at Ipca’s analytical laboratory. During the inspection, FDA investigators spoke to an analyst who reported that “…if we find a failure, we set back the date/time setting and re-integrate to achieve passing results…” The analyst explained such manipulation was done for raw materials, in-process testing, and finished API drugs. Barbara Unger’s blog shares a summary of the deceptive practices of data manipulation “that were known to and supported by the management”.

Ind-Swift maybe next to hit the regulatory wall

India’s Ind-Swift Laboratories seems the next company to run into compliance trouble as Health Canada’s inspection tracker has listed data integrity concerns uncovered by “a trusted regulatory partner”. The tracker provides a snapshot of the potential health and safety issues Health Canada is tracking “with companies that fabricate, package/label, test, wholesale, distribute or import drugs for sale in Canada”. Our previous experience indicates that it is just a matter of time before Ind-Swift is either on the FDA’s or on a European regulatory scanner.

Taizhou Xinyou on FDA import alert list

Taizhou Xinyou Pharmaceutical and Chemical in Zhejiang district of China manufactures APIs for repackagers and distributors, some of which sell these products to compounding facilities in the US. When the FDA contacted Taizhou through its agent in the US, the company confirmed that the baclofen API it manufactures is not suitable for use in injectable drugs. In December 2015, the USFDA warned drug compounders about the risk of using baclofen API from Taizhou. And this month, Taizhou has made it to the FDA import alert list for refusing to accept an FDA inspection.

42 deficiencies uncovered at Svenska Bioforce in Sweden

It’s not just drug manufacturers from China and India that are slackening control on good manufacturing practices (GMP). Sweden-based Svenska Bioforce AB had 42 deficiencies uncovered during a GMP inspection which failed to convince inspectors that the company’s Pharmaceutical Quality System meets the EU-GMP requirements.

FDA seeks US $ 5.1 billion budget for food safety

The US Food and Drug Administration has requested a total budget of US $ 5.1 billion to protect and promote public health as part of the President’s budget for the 2017 fiscal year. This is an 8 percent increase over the budget enacted for the 2016 fiscal year. The budget would be used to implement

food safety law, improve medical product safety and quality. The agency is also seeking US $ 75 million in new mandatory funding to support the National Cancer Moonshot initiative led by the Vice President.

India protects domestic drug-makers by lifting customs exemptions

Last week, the Indian government withdrew custom exemptions on 74 drugs, including lifesaving ones used to treat cancer and HIV. The move is intended to provide protection to domestic manufacturers and enhance the attractiveness of the ‘Make in India’ initiative, analysts said. As a result, several drugs may see a spurt in prices. The list includes medicines used to treat kidney stones, cancer chemotherapy and radiotherapy, life-threatening heart rhythm disorders, diabetes, Parkinson's disease, bone diseases, antibiotic to treat infections, drugs used for bacterial infections, leukemia, anesthetic medication, HIV or hepatitis B virus cells, allergies, arthritis, lupus and ulcerative colitis.

Concerns raised over Entresto’s alarmist advertisement

Novartis’ new heart failure drug Entresto is expected to generate US $ 5 billion in peak sales. However, Novartis’ advertising campaign used to sell Entresto and cash in on its potential has been called “alarmist,” “terrifying” and “shameful” by CardioBrief. The ad depicts a middle-aged man in an easy chair reading the newspaper, oblivious to a rising flood that threatens to drown him, though his dog, climbing onto a couch for safety, expresses considerable anxiety.

Scientists figure out why hair thins with age

If hair loss has concerned you, Stat News covered the progress scientists have made to understand why our hair thins as we age. According to this report, two new studies point at the scalp’s constantly-renewing stem cells. Mutations in these cells appear to make hair follicles shrink, causing regular hair to be replaced by thin wisps. Understanding the genes at work in this process may allow scientists a way to prevent such hair loss. While a treatment is still not on the horizon, the path of progress has never followed a straight path.

Explosion at a drug intermediate plant in Hyderabad kills six

An explosion at a company based in Hyderabad that makes drug intermediates killed six people. According to a report “a nutsche filter attached to a reactor exploded, killing those standing close to it.” The unit is owned by Hasita Aromatics Private Ltd, a small-scale company based in Hyderabad. There are dozens of chemical factories operating in the industrial estates located around Hyderabad. And several such incidents have occurred in the past, in this region.

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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