Trumpcare Receives a Blow; EMA to Suspend 300 Drugs Due to Clinical Data Integrity Violations in India

Trumpcare receives a blow; EMA to suspend 300 drugs due to clinical data integrity violations in India

This week, Phispers takes you to the US, where President Trump’s efforts to repeal and replace Obamacare received a setback. There is also news that the EMA has recommended suspending over 300 drugs due to data integrity concerns at a CRO based in Chennai — Micro Therapeutics — along with news on drug makers like Teva, Pfizer and Stada. Read on.

More scrutiny for Pfizer as injectable facility in India comes under FDA lens

Pfizer’s fill/finish manufacturing facility in the United States recently received a warning letter from the US Food and Drug Administration (USFDA). In February 2015, Pfizer had acquired the site in McPherson (Kansas) through its US $17 billion acquisition of Hospira. Pfizer was aware of Hospira's manufacturing record when it struck the deal, as the company was issued FDA warning letters on four of the seven continents — Europe, North America, Asia and Australia.

Last week, a Hospira facility in Visakhapatnam in India, set up to manufacture specialty injectables at an anticipated cost of US $375-450 million, received 11 observations from the US drug regulator. An inspection by the US FDA took place at the sterile injectables manufacturing unit between March 9 and 17 this year.

An initial audit had taken place in 2015, during which 14 observations had been found. The company responded to the observations in March 2015 and submitted additional support documentation by the end of May 2015.

“The inspection was found to be acceptable following the FDA's review of the company's responses and support documentation. The company has begun limited commercial production at the facility,” the company had said.

The latest list of FDA observations includes three repeat observations related to air supply, air sampling and the root cause for microbial contamination.

Last year, Pfizer had to halt production at its Chennai plant, which was also obtained as part of the Hospira acquisition, due to quality concerns.

EMA endorses suspending 300 drugs due to clinical data integrity pitfalls

Late last year, the European Medicines Agency (EMA) had raised data-integrity concerns over another contract research organization (CRO) in India — Chennai-based, Micro Therapeutics Research Labs. The concerns had regulators reviewing the data of over 300 generic medicines being sold across Europe.

Last week, the EMA announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bio-equivalence studies were conducted at Micro Therapeutic Research Labs.

The review concluded that data from studies conducted at two sites between June 2012 and June 2016 was “unreliable and cannot be accepted as a basis for marketing authorization in the EU.” However, there is no evidence of harm or lack of effectiveness of these medicines.

EMA’s list of drugs it is recommending for suspension covers just about every EU member state, including Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal, Spain, The Netherlands and the UK.

Generic drugs recommended for suspension include those being marketed by Novartis’ Sandoz, Sanofi’s Zentiva, Teva, Aurobindo Pharma and others. It includes dosage forms containing the active substances bupropion, voriconazole, betahistine, amlodipine/valsartan, tadalafil and naproxen.

Though not a manufacturing compliance issue, clinical data-integrity has made headlines recently as labs across India had their data invalidated due to data-integrity concerns. Clinical trial falsification issues at the labs of Quest Life Sciences, GVK Biosciences, Alkem Laboratories, Semler Research Center and now Micro Therapeutics indicate that a sustained supply of generics can no longer be taken for granted.

Struggling Teva to slash jobs to improve profitability

Things haven’t been going right for the Israeli generic drug giant Teva for quite sometime now. First, it’s CEO Erez Vigodman left the company. Second, its books were debt-ridden post the acquisition of Allergan Plc in July 2015. Third, its R&D has not seen a breakthrough in years. And now, Teva is said to be going in for major layoffs.

The Israeli newspaper Calcalist reported that Teva is planning to cut 6,000 staffers (or 11 percent of its global workforce) after Passover. The company, however, denied this by saying it won’t layoff thousands. Instead, Teva said it is ending certain activities, consolidating operations and freezing new recruitments.

“The efficiency program is an integral part of Teva’s business reality. The program includes, among other things, ending unprofitable activities and consolidating functions, in addition to freezing recruitment and natural employee turnover,” the company said.

Teva is also looking for a new CEO to turn around the business after its US $ 40.5 billion acquisition of Allergan’s generic business pushed it into debt.

Trump's plan to repeal and replace Obamacare suffers a major setback

For seven years, the Republican Party has pursued repealing Obamacare like an obsession. But on Friday last, Speaker Paul Ryan and US President Donald Trump withdrew the bill at around 3.30 in the afternoon.

Ryan could not bridge the ideological gap between the center and the far right within the Republican Party. The first presentation of Trumpcare couldn’t pass, as it was not sufficiently hard-hearted for the far-right members of the Freedom Caucus. But Trump and Ryan kept tweaking the bill to appease the hardliners. They even did away with the essential benefit guarantees that health insurance plans in American must now cover. And then the bill lost supporters at the center.

The Bill fell short of around a dozen votes to get a winning vote count. The Congressional Budget Office had said the bill would deprive 24 million Americans of insurance coverage, while only saving the federal government US $ 151 billion.

Meanwhile, Trump sought to spread blame for the failure of his first attempt at replacing Obamacare. He said: “Bad things are going to happen to Obamacare. There's not much you can do to help it”.

On Sunday morning, Trump wrote on Twitter: “Democrats are smiling in DC that the Freedom Caucus, with the help of Club for Growth and Heritage, have saved Planned Parenthood & Obamacare.”

However, latest reports signal that Trump hasn’t given up hope. On Tuesday, he spoke to a “semi-bipartisan” group of Democratic and Republican senators and their spouses in the White House, where he signaled support for another run at a new GOP health care bill. Trump hopes a second go-around will be more successful.

Stada CEO finds his car bugged amid takeover talks

Germany’s Manager Magazin reported last week that the chief executive of German drugmaker Stada — Matthias Wiedenfels — found a bugging device in his car.

Stada has faced pressure to overhaul its strategy and has also received two takeover approaches. Wiedenfels, who became the CEO of Stada last summer, also received anonymous letters containing photographs that depict him in private or confidential business situations, the magazine said.

The magazine, which did not cite sources or give information on those behind the bugging, said the incidents took place in the second half of 2016. Stada, however, did not comment on this report.

Stada is the subject of takeover approaches from two private equity consortia. It has postponed the structured auction to give the bidders a chance to improve their offers which last valued the company at $3.9 billion.

Over 1,100 drugs in Australia to become cheaper from next month

From April 1, millions of Australians will benefit from reduced prices of more than 1,100 medicine brands. Vital drugs have been added to Australia’s Pharmaceutical Benefits Scheme (PBS).

The price of drugs used in conditions like high cholesterol, Parkinson’s disease, depression, breast cancer, eczema and psoriasis will cost lesser. For instance, 467,000 Australians using rosuvastatin for high cholesterol will save 22 percent per script.

According to Australia’s Health Minister Greg Hunt, “sick Australians will save $500 million (US $ 383 million) over four years and up to $200 (US $ 153 million) a year each on the cost of medicines.”

The country also plans to list new drugs on its PBS. These include drugs for two rare cancers — Hodgkin’s lymphoma, and an advanced type of skin cancer — and treatments for psoriasis, arthritis, schizophrenia and iron deficiency. Hunt said the savings for patients would be "considerable".

The PharmaCompass Newsletter – Sign Up, Stay Ahead

Feedback, help us to improve. Click here

Image Credit : i voted today by Robert Couse-Baker is licensed under CC BY 2.0

“ 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.”

BLOG

MARKET INTEL by PharmaCompass

CONTENT by Suppliers

News