Blog Coverage Pfizer Gets Negative News from UK’s MHRA and Positive News from US FDA

LONDON, UK / ACCESSWIRE / August 22, 2016 / Active Wall St. blog coverage looks at the headline from Pfizer Inc. (NYSE: PFE). UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement on August 19, 2016, of non compliance against Pfizer Inc.’s (NYSE: PFE) India-based site on all medicinal products that are considered “non-critical” to public health. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

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Implications of MHRA’s statement

The implication of MHRA’s statement starts with its recommendation for the withdrawal of the Indian site’s UK GMP certificate. This will lead to an effective EU wide ban for all future batches of non-critical sterile products being supplied until such time that the suspension order is in place. Among the products banned from the EU were Piperacillin/Tazobactam and Cefuroxime. This ban does not cover tablets and capsules, which are considered as solid-dosage products.

History behind MHRA’s statement

On August 8, 2016, Pfizer had agreed to an inspection of its Irungattukottai site, close to Chennai, India as a compliance of good manufacturing practice (GMP) regulations. Pfizer had gained this site as a part of its acquisition of Hospira’s business in September 2015 for $16 billion. The inspection was conducted jointly by officials of four regulators – the US Food and Drug Administration (FDA), UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Australia’s Therapeutic Goods Administration (TGA), and Health Canada. This joint exercise was unique as each site is re-inspected individually by the regulators never simultaneously. However, the findings of the officials of the inspection had led to the temporary suspension of the site.

Causes for concern

MHRA’s had major issues with the products being manufactured at this site as it was not sure that the injectable products coming out of this facility were sterile. According to the MHRA, ‘The inspection identified a critical finding that was in regards to sterility assurance of product. The deficiency covered a number of areas including building classification and segregation by pressure differentials, aseptic processes that had not been optimized to reduce the risk of microbial contamination, aseptic process simulation investigations that failed to identify root cause and take appropriate actions.”

MHRA’s findings pointed out the lack of scientific application of technology to the manufacturing process. Earlier, US FDA in 2013 had issued a warning letter to Pfizer for deficiencies at its site at Irungattukottai. Pfizer had initiated a number of initiatives to address the concerns including employee training.

Pfizer’s issues with Hospira’s assets

Pfizer has been facing difficulties with regards to the assets acquired even in US as a part of the Hospira deal. On August 19, 2016, it has announced the closure of four of its legacy distribution units at Atlanta, Dallas, Los Angeles and King of Prussia, Pennsylvania. Pfizer had recently announced closure of the manufacturing facility at Boulder, Colorado. However, the current findings bring into question the effectiveness of measures undertaken by Pfizer and its ability to manufacture sterile drugs which will meet global standards at the Irungattukottai site.

US FDA gives good news

On a positive note, the US FDA has approved Pfizer’s oral use, extended-release capsule – TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride). This medication is an alternative for management of long-term pain that requires opioid treatment. However, its USP is in its anti-abuse deterrent features. The abuse deterrent features were tested through in-vitro laboratory studies and three clinical abuse-potential studies.

Stock Performance

Shares of Pfizer dipped slightly by 0.60%, finishing the day at $34.98 at the close on August 19, 2016. A total volume of 19.03 million shares changed hands. The company’s stock price has advanced 18.42%, in the past six months and 11.35% on an YTD basis.

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