Pfizer Fined £84.2 Million Over Epilepsy Drug

The pharmaceutical company Pfizer has been find a record £84.2 million by the competition regulator in Britain.

This followed the unfair raising of prices related to an anti-epilepsy drug, with Pfizer charging an additional 2,600% as a result of the hikes.

The Competition and Markets Authority (CMA), issuing its largest ever fine, stated that the “extraordinary price rises have cost the NHS and the taxpayer tens of millions of pounds”.

Pfizer responded strongly to the comments of the CMA, intending its intention to appeal against the decision.

Before September 2012, Pfizer manufactured and sold phenytoin sodium capsules to UK wholesalers and pharmacies under the brand name Epanutin.

The corporation later sold the UK distribution rights to Flynn Pharma, removing branding and ensuring that the drug became generic.

At this point, the drug was no longer subjected to price regulations, resulting in the extortionate prices later charged by Pfizer.

The NHS was subsequently charged £67.50 per 100mg pack, as opposed to the £2.83 it had cost previously.

This resulted in the amount that the NHS spends on phenytoin sodium capsules increasing 25-fold in just 12 months, from £2 million to £50 million annually in 2013.

It was also revealed that the price charged for anti-epilepsy drugs in the UK is higher than in any other European nation.

Philip Marsden, who led the investigation for the CMA, believes that Pfizer have been fundamentally exploitative.

“The companies deliberately exploited the opportunity offered by debranding to hike up the price for a drug which is relied upon by many thousands of patients. These extraordinary price rises have cost the NHS and the taxpayer tens of millions of pounds. This is the highest fine the CMA has imposed and it sends out a clear message to the sector that we are determined to crack down on such behaviour and to protect customers.”

Pfizer suggested that it had been losing money on drugs before adjusting prices, and a statement outlined its dissatisfaction with the verdict of the CMA.

“Pfizer refutes the findings set out in the Competition and Markets Authority decision. In this transaction, and in all of our business operations, we approached this divestment with integrity, and believe it fully complies with established competition law. Phenytoin capsules were a loss-making product for Pfizer and the Flynn transaction represented an opportunity to secure ongoing supply of an important medicine for patients with epilepsy, while maintaining continuity of manufacture. Pfizer believes the CMA’s findings are wrong in fact and law and will be appealing all aspects of the decision”.

Pfizer reported a profit of over $2 billion in the most recent financial year.

 
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FDA Approves Major New Lung Cancer Medication

Health regulators in the United States have indicated that they have granted approval to an advanced lung cancer medication.

The drug in question is produced by the pharmaceutical manufacturer Roche Holding, and addresses lung cancer in patients with a specific genetic mutation.

Roche Holding will be selling the drug, alectinib, under the brand name Alecensa.

The medication has been approved with the intention of treating patients with advanced ALK-positive non-small cell lung cancer (NSCLC).

Alecensa will be particularly effective in treating those patients within whom this disease has worsened after, or who could not tolerate, treatment with competitor Pfizer’s Xalkori.

There are hopes that the drug will now be approved for wider marketplaces as well, as Roche Holding looks to increase its share of the lung cancer pharmaceutical marketplace.

“Today’s approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori,” Richard Pazdur, head of the Food and Drug Administration’s Hematology and Oncology Products division, commented in an official statement.

Xalkori was seen as an advance in the field of personalised medicine as it was designed to treat only patients with the ALK genetic mutation.

This is a relatively tiny portion of overall cancer sufferers, with this specific group accounting for only 4% of NSCLC patients.

As competition hots up in this particular area of pharmaceuticals, it has been reported that Pfizer is also developing a drug for ALK.

The pharmaceutical heavyweight has had to acknowledge that many patients have stopped responding to its own products Xalkori, and Pfizer is attempting to develop an alternative remedy.

Pfizer has established itself as one of the 50 largest corporations in the world according to Forbes magazine, with a market capitalisation in excess of $200 billion.

The pharmaceutical lobby is famously one of the most influential groupings in the United States, and indeed the industry spends more on lobbying government than any other comparable industrial sector.

While the United States pharmaceutical industry unquestionably produces many valuable medicines, the country has also been criticised for its reliance on responding to illnesses with drugs, as opposed to addressing the cause of problems.

Indeed, the US has something of an addiction to popping pills, with the country one of only two in the world that allows the television advertising of drugs (the other being New Zealand).

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence of clinical benefit.

A confirmatory study is required to verify the benefit of Alecensa for it to gain full approval, the agency revealed.

There are an estimated 158,040 deaths from lung cancer annually in the United States (86,380 in men and 71,660 among women).

 
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