Press review


Trade bodies take action to stop U.S. states introducing drug pricing laws

Country : Australia, U.S., UK

Keywords :
LONDON, Oct 20 (APM) - Pharma trade bodies in the U.S. are taking action to fight a string of new laws being passed in U.S states to curb high drug prices, the Financial Times reported at the weekend.
Individual states have introduced more than 100 bills targeting drug prices during the most recent legislative session, compared with 92 in 2015 and 2016 combined. This includes California’s decision last week to sign a transparency law that forces pharma companies to give advance notice of price increases.
The Association for Accessible Medicines, the trade group for generic drug companies, is leading the battle against a recently passed law in Maryland which gives state officials broad powers to punish generic companies that introduce the very large price increases known as “gouging”.
Its president told the FT the group might have to ask its members for more cash to fund the effort.
Priscilla VanderVeer, deputy vice-president at PhRMA, the industry trade group, said: “States can have an easier time getting legislation passed. They don’t have the same barriers we often see at the federal level.”

FDA approves cancer therapy - with $373,000 tag

Thursday's Financial Times reported U.S. approval of Kite Pharma’s cell-based therapy treatment for patients with advanced lymphoma, marking the second approval for a cutting edge cancer treatment known as CAR-T (APMHE 55223).
Gilead Sciences, which bought Kite Pharma earlier this year, said the price for Yescarta, a therapy known as as chimeric antigen therapy, would be $373,000. The process involves extracting a person’s cells and re-engineering them to attack and kill cancer cells.
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” said FDA Commissioner Scott Gottlieb.
“This approval demonstrates the continued momentum of this promising new area of medicine and we’re committed to supporting and helping expedite the development of these products.
The win for Gilead comes after Novartis secured approval in August to use CAR-T to treat a type of leukaemia in children and young adults. Novartis said it would charge $475,000 a patient for its therapy.

Aspen forced UK government to pay inflated fee

The Times on Thursday said a pharmaceutical company increased the cost of life-saving cancer drugs by up to 600% and warned the Health and Safety Executive (HSE) of “severe stock shortages” if it refused to agree to its price demands.
Aspen, which has its EU headquarters in Dublin, pushed through price increases on four chemotherapy drugs used to treat cancers including acute forms of leukaemia, ovarian cancer and Hodgkin lymphoma.
In a series of emails with the HSE in late 2012, Aspen repeatedly warned it was “hesitant to replenish” its stock of drugs until the price increases were approved, and warned of “severe stock shortages” if the Irish authorities failed to approve them, the paper said.
Documents show that the HSE told Aspen it was operating under significant economic constraints caused by the downturn, but eventually caved in to the demand out of fear that the products would be withdrawn.

SMC chairs says expensive cancer drugs may mean patients in Scotland miss out on other treatments

Monday’s Times included an interview with the chairman of the Scottish Medicines Consortium (SMC) in which he warned that the money the NHS in Scotland would need to spend on cancer drugs for dying patients came at the cost of being unable to afford other treatments for patients that might improve their lives for longer periods. (APMHE 55166)
Dr Alan MacDonald said the body had backed these cancer products under direction from the Scottish government.
The SMC has had to revisit earlier decisions not to approve drugs it had previously rejected on cost-effectiveness grounds because of public and political pressure, including Roche’s Kadcyla (Trastuzumab emtanzine) for breast cancer.
MacDonald said that by giving approval for more and more new drugs to be used, “there is a risk that in some situations it is encouraging therapeutic futility” as their long-term effectiveness was not always proven.

U.S. judge rules invalidates patent on Allergan's Restasis

A U.S. judge has said the intellectual property covering Allergan’s Restasis is invalid, opening the way for generic competitors Mylan and Teva to market a cheaper copycat version of the prescription eye drop, the FT said on Monday. (APMHE 55181)
The paper said Restasis generated roughly $1.5 billion in sales for Allergan last year and is the company’s second best-selling medicine behind Botox, the wrinkle treatment. Analysts said they expected Allergan to appeal the ruling.
The court decision was not related to a separate attempt by Allergan to protect its patents from challengers, which saw the company take the unusual step of transferring its IP to a Native American tribe.

Shares in Benetic Biopharma up on hepatitis B treatment patent

Shares in Australia’s Benetic Biopharma jumped as much as 27% on Wednesday after the company announced it had received a U.S. patent related to its treatment for hepatitis B, the FT said.
The patent encompasses the company’s gene silencing agent - known as RNA interference - and use of that agent to treat people infected with the virus.

U.S. veterans sue five pharma companies for funding Iraqi terrorist militia

Several U.S. veterans and relatives of American soldiers killed or wounded in Iraq are suing five pharmaceutical and medical equipment makers, saying the companies in effect funded an Iraqi terrorist militia, the FT said on Tuesday.
The civil lawsuit, filed in federal court in Washington, accuses AstraZeneca, General Electric, Johnson & Johnson, Pfizer and Roche Holding of routinely bribing Iraqi Ministry of Health officials to win drug contracts when the office was controlled by the Jaysh al-Mahdi or Mahdi Army. (APMHE 55208)
Corporate bribery helped fund the Mahdi Army’s acquisition of weapons, training and logistical support to attack the U.S. from 2005 to 2009, the lawsuit claims.
Among the goods sold to Iraq were AstraZeneca’s anti-psychotic Seroquel; GE’s electrocardiogram machines; catheters and anti-epilepsy drugs made by J&J; Pfizer’s Depo-Provera birth control shot; and Roche’s breast cancer drug Herceptin, the lawsuit claims.

U.S. congressman withdraws from drug tsar nomination

Tom Marino, a Pennsylvania congressman tapped to head the U.S. Office of National Drug Control Policy, withdrew his nomination after reports about his role passing legislation that weakened the ability of the government to prevent drug companies from selling various opioids, the FT said on Tuesday.
“Tom Marino has informed me that he is withdrawing his name from consideration as drug tsar. Tom is a fine man and a great Congressman!” president Donald Trump tweeted on Tuesday.
Marino came under heavy fire after the Washington Post and CBS news show 60 Minutes reported that he was instrumental in helping drug companies convince the justice department and Drug Enforcement Administration to accept a watered-down piece of legislation that made it harder for the DEA to crack down on companies supplying opioids.



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