Market Place
This week, the US Senate cleared the 21st Century Cures bill, touted as the most significant reform in medical treatments. Phispers also brings you news on a court order that reverses a ban on 344 fixed-dose combination drugs in India, a shouting match between head honchos of pharma companies at a healthcare summit, a court order on J&J’s hip implant, and a warning letter to Interquim.
US Senate clears Cures Act — the biggest reform on medical treatments
On Wednesday, the US Senate passed the landmark 21st Century Cures Act. The bill had passed the House on November 30 and had advanced through the Senate earlier this week. After the vote, President Barack Obama said he would sign the measure “as soon as it reaches my desk.”
The 21st Century Cures Act is a labyrinthine bill that would bring about significant changes in the way medical treatments are tested and brought to market over the coming decades.
The legislation calls for the use of ‘data summaries’ to support the approval of certain drugs for new indications, rather than full clinical trial data. The Cures Act will also allow drug companies to promote off-label uses to insurance companies, allowing them to expand their markets.
It includes ambitious goals to advance biomedical science, and will inject US $ 4.8 billion into a long-stagnating National Institute of Health budget.
Critics call this deregulation, and a wolf in sheep’s clothing. They worry that both science and patients are going to suffer. They have argued the legislation is too friendly to Big Pharma, won’t curb high drug prices and may lead to unsafe treatments being put on the market. Tucked away in the 99-page bill are provisions that are likely to weaken the authority of the FDA as the bill includes language to put forward “real-world evidence” to support the approval of a new indication (or use) for an existing drug.
Indian
court quashes ban on fixed dose combination drugs
As the 21st Century Cures Act will take us to an era of ‘inject and see’, the Indian government may want to see if the debate on banning fixed-dose combination (FDC) drugs can be resolved using ‘real-world evidence’.
A government order banning 344 FDC drugs was overturned last week when the court was hearing a plea filed by pharmaceutical companies challenging the March 10, 2016 order which banned 344 FDC drugs.
The ban included several common cough syrups, analgesics (pain killers) and anti-diabetes combinations.
Pharmaceutical companies’ argued that the government’s action had been ad hoc in nature and is not aligned with the procedures mentioned under Section 26A of the Drugs and Cosmetics Act, 1940. They argued that the decision was taken without considering clinical data. And that it was based on an ‘absurd’ claim that there are safer alternatives available in the market today.
Pfizer fined US $ 106.5 million in UK for hiking price of epilepsy drug
The Competition and Markets Authority in the UK fined Pfizer a record US $ 106.5 million (GBP 84.2 million) for its role in increasing the cost of an epilepsy drug by a whopping 2,600 percent. The CMA also fined Flynn Pharma US $ 6.58 million (GBP 5.2 million) for overcharging for phenytoin sodium capsules.
The ruling comes at a time when there is a growing debate both in the US and Europe about the ethics of price hikes for old off-patent medicines that have little competition.
Pfizer used to market the (epilepsy) medicine under the brand name Epanutin, but sold the rights to Flynn, a privately owned British company, in September 2012. It was then debranded — i.e. it was no longer subject to price regulation — and the price soared.
“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,” Philip Marsden, chairman of the CMA’s case decision group, said.
“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,” Marsden added
Pfizer, Regeneron CEOs get into a shouting match at
healthcare summit
At the Forbes Healthcare Summit held last week, a panel featuring Gilead CEO John Milligan, Pfizer CEO Ian Read, incoming Eli Lilly CEO David Ricks, Astellas Americas President Jim Robinson, and Regeneron CEO Leonard Schleifer were asked to contemplate on why the pharma industry isn't liked.
While the panel discussed middlemen and adding value, Schleifer offered his own take.
“I think you've just seen why our industry isn't liked. You've asked a question why we're not liked, we are a room full of people who are biased to like us, and nobody answered the question why we're not liked,” Schleifer said.
“We dispelled of some of it last year, because we blamed it on the extremists, the people who come in, dial up a product that's off patent, raising price ten-fold and they're evil-doers, that's why we're not liked,” he continued. “But the real reason we're not liked, in my opinion, is because we as an industry have used price increases to cover up the gaps in innovation. That's just a fact.”
Pfizer’s Read countered this with an often cited statistic that drug costs as a percentage of healthcare expenses haven’t changed in two decades, regardless of price increases.
Schleifer’s response: “You’re not entitled to a fraction of the GDP.”
What followed was a shouting match, until a member of the panel interjected.
The pharma industry surely needs a unified message to send out to the world.
Spain’s Interquim gets FDA warning letter for using dirty equipment
The latest company to receive a warning letter from the FDA is Interquim SA of Spain. FDA investigators found the presence of residue in the interior surfaces of non-dedicated drug manufacturing equipment at Interquim that were labeled “clean.”
Inadequate removal of residues from manufacturing equipment during cleaning can lead to cross-contamination of API subsequently manufactured, using the same equipment.
Investigators also questioned the impact on API quality of the product produced from equipment whose interior surfaces were discolored even after an equipment maintenance contractor had previously noted the damage and repaired it.
Interquim
is a part of Ferrer, an international group of more than 50 companies with
activities in the pharmaceutical, hospital, diagnostics, fine chemicals, feed
and food sectors. Headquartered in Spain, its products are sold in more than 70
countries. It is a leading manufacturer of APIs like Celecoxib, Imiquimod, Paliperidone Palmitate, Rivaroxaban, Rivastigmine, etc.
Explosion at excipient manufacturer in India claims two lives
An explosion at a manufacturer of pharmaceutical excipients — Nitika Pharmaceutical Specialities — in India claimed two lives and injured 19 others.
While initial news reports claimed a boiler explosion, a report submitted by the inspector of boilers stated: “The explosion at M/s Nitika Pharmaceuticals Pvt Ltd is not a case of boiler explosion. There is no registered or exempted or unauthorized boiler in the unit. The heat requirement of the factory was being catered to by two thermic fluid heaters installed in the factory.”
The local police arrested the company’s senior manager (operations), the senior manager (maintenance) and its managing director, who were later granted bail by the court.
Cannabis cultivation to get boost due to upcoming approvals
GW Pharmaceuticals, a UK-based company focused on developing medicines from marijuana, plans to expand manufacturing in the UK and boost cultivation of the cannabis plants it uses to make a treatment for severe epilepsy.
The British biotech firm is gearing up to submit Epidiolex — an experimental drug that has shown to be hugely effective in treating rare and life-threatening forms of childhood epilepsy —with US regulators in the first-half of 2017. Approval could come by early 2018.
It was just
last week that PharmaCompass covered the news of the medical cannabis sector managing to comply with pharmaceutical standards for inhalation. Israel’s Teva Pharmaceuticals has partnered with Tel Aviv-based Syqe Medical
to market medical cannabis in Israel for pain management.
Will Apple launch FDA regulated cardiac monitoring products soon?
A collection of emails obtained by MobiHealthNews, through a Freedom of Information Act request to the FDA, indicates that since July 2016, Apple has been in discussions with the FDA about two FDA-regulated products in the cardiac monitoring space.
In an interview with the Telegraph last year, Apple CEO Tim Cook had also hinted at a regulated medical device from Apple.
“We don’t want to put the Watch through the Food and Drug Administration (FDA) process,” he said at the time. “I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it — maybe an app, maybe something else,” Cook had said.
J&J to pay over US $1 billion in Pinnacle hip implants case
Last week, a federal jury in Dallas ordered Johnson & Johnson and its unit DePuy Orthopaedics to pay more than US $ 1 billion to six plaintiffs who said they were injured by the Pinnacle hip implants.
According to the jurors, the metal-on-metal Pinnacle hip implants were defectively designed. And both companies failed to warn consumers about the risks. J&J and DePuy have been hit with nearly 8,400 lawsuits over the devices.
However, verdicts of such size are often lowered by courts. In July, the judge presiding over this case reduced a US $ 500 million verdict in an earlier Pinnacle implant case to US $ 151 million by citing a Texas state law that limits punitive damages awards.
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