A drug sold for years overseas to treat a rare form of muscular dystrophy was OKed Thursday by the FDA to be sold in the US, but it comes at a high price. The Wall Street Journal reports the now-FDA-approved deflazacort will be offered by Marathon Pharmaceuticals for $89,000 or so a year, up to 70 times its cost outside the US; Marathon CFO Babar Ghias tells the Washington Post the net price will be $54,000 after rebates and discounts. Some who rely on it to treat Duchenne muscular dystrophy—an incurable disease most often affecting boys and typically leading to death by one's 30s—are afraid they won't be able to afford it if insurance won't pay for it or if deductibles are too high. The drug, which Ghias tells the Journal will be sold under the brand Emflaza starting in March, is a steroid that helps mitigate muscle weakness and cut inflammation, per an FDA release.
Emflaza is also said to cause fewer side effects than prednisone, a non-FDA-approved drug often prescribed for DMD, per Reuters. Marathon had to invest money in new trials before the FDA would approve US sales. And, like other pharma companies that scoop up "orphan drugs"—meds used for diseases that don't affect more than 200,000 people nationwide—Marathon says the high cost is justified because of the money it has poured into R&D. A Massachusetts woman who's been buying the drug for her son for $1,600 a year from a UK online pharmacy isn't seeing it the same way, telling the Journal she's "disappointed" Marathon boosted her cost "by more than $87,000 a year." Because the FDA has approved a drug to treat the disease, US consumers won't be legally able to acquire it overseas at the cheaper price anymore.
___________________________________
This came days after Trump decided not to get tough with pharma companies.
31 Jan 2017
A lot happened in the 2016 campaign, but one of the things Donald Trump did to win the election was shift to the left on a number of key issues — promising to avoid cuts in Social Security and Medicare benefits and adopting a longstanding Democratic pledge to let Medicare negotiate bulk discounts in the price it pays for prescription drugs.
Today, after a meeting with pharmaceutical industry lobbyists and executives, he abandoned that pledge, referring to an idea he supported as recently as three weeks ago as a form of “price fixing” that would hurt “smaller, younger companies.” Instead of getting tough, Trump’s new plan is that he’s “going to be lowering taxes” and “getting rid of regulations.”
New drugs are generally covered by patent monopolies, so drug companies have a lot of pricing power; other companies can’t produce the same drug without paying royalties, so there’s little competition. But most countries use their nationalized health care systems to negotiate a good deal on drug prices. Manufacturing pills is cheap, so it’s usually still profitable for a company to sell medicine at a pretty steep discount.
The United States doesn’t have a nationalized health care system, but we do have Medicare for senior citizens, and since the USA is a very large country, that’s still a huge potential bulk purchaser. But a 2003 law written by congressional Republicans and signed by George W. Bush prohibits the federal government from using that negotiating power.
As recently as January 11, President-elect Trump was promising to revisit this policy.
“Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there’s very little bidding on drugs,” he said at a press conference at Trump Tower in Manhattan. “We’re the largest buyer of drugs in the world, and yet we don’t bid properly.”
Today he apparently changed his mind. According to Herb Jackson, the designated pool reporter for the day, Trump’s new policy on prescription drugs is that drug companies should get tax cuts and deregulation (emphasis added):
I'll oppose anything that makes it harder for smaller, younger companies to take the risk of bringing their product to a vibrantly competitive market. That includes price-fixing by the biggest dog in the market, Medicare, which is what's happening. But we can increase competition and bidding wars, big time.
So what I want, we have to get lower prices, we have to get even better innovation and I want you to move your companies back into the United States. And I want you to manufacture in the United States. We're going to be lowering taxes, we're going to be getting rid of regulations that are unnecessary.
Many people watching the chaotic rollout of Trump’s executive orders on immigration, his demands for investigations into phantom vote rigging, his mysterious ties to Russia, his financial conflicts of interest, and his bizarre lies about Inauguration Day crowd size have found themselves wondering why more Republicans don’t stand up to him.
This event with PhRMA lobbyists explains why. On most of the big public policy issues of the day, Trump is a very conventional Republican. And on those issues where he hasn’t been conventional, Republican Congress members and business executives feel confident they can turn him around. On some issues, they probably won’t. But on this issue, it seems like they did.
Emflaza is also said to cause fewer side effects than prednisone, a non-FDA-approved drug often prescribed for DMD, per Reuters. Marathon had to invest money in new trials before the FDA would approve US sales. And, like other pharma companies that scoop up "orphan drugs"—meds used for diseases that don't affect more than 200,000 people nationwide—Marathon says the high cost is justified because of the money it has poured into R&D. A Massachusetts woman who's been buying the drug for her son for $1,600 a year from a UK online pharmacy isn't seeing it the same way, telling the Journal she's "disappointed" Marathon boosted her cost "by more than $87,000 a year." Because the FDA has approved a drug to treat the disease, US consumers won't be legally able to acquire it overseas at the cheaper price anymore.
___________________________________
This came days after Trump decided not to get tough with pharma companies.
31 Jan 2017
A lot happened in the 2016 campaign, but one of the things Donald Trump did to win the election was shift to the left on a number of key issues — promising to avoid cuts in Social Security and Medicare benefits and adopting a longstanding Democratic pledge to let Medicare negotiate bulk discounts in the price it pays for prescription drugs.
Today, after a meeting with pharmaceutical industry lobbyists and executives, he abandoned that pledge, referring to an idea he supported as recently as three weeks ago as a form of “price fixing” that would hurt “smaller, younger companies.” Instead of getting tough, Trump’s new plan is that he’s “going to be lowering taxes” and “getting rid of regulations.”
New drugs are generally covered by patent monopolies, so drug companies have a lot of pricing power; other companies can’t produce the same drug without paying royalties, so there’s little competition. But most countries use their nationalized health care systems to negotiate a good deal on drug prices. Manufacturing pills is cheap, so it’s usually still profitable for a company to sell medicine at a pretty steep discount.
The United States doesn’t have a nationalized health care system, but we do have Medicare for senior citizens, and since the USA is a very large country, that’s still a huge potential bulk purchaser. But a 2003 law written by congressional Republicans and signed by George W. Bush prohibits the federal government from using that negotiating power.
As recently as January 11, President-elect Trump was promising to revisit this policy.
“Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there’s very little bidding on drugs,” he said at a press conference at Trump Tower in Manhattan. “We’re the largest buyer of drugs in the world, and yet we don’t bid properly.”
Today he apparently changed his mind. According to Herb Jackson, the designated pool reporter for the day, Trump’s new policy on prescription drugs is that drug companies should get tax cuts and deregulation (emphasis added):
I'll oppose anything that makes it harder for smaller, younger companies to take the risk of bringing their product to a vibrantly competitive market. That includes price-fixing by the biggest dog in the market, Medicare, which is what's happening. But we can increase competition and bidding wars, big time.
So what I want, we have to get lower prices, we have to get even better innovation and I want you to move your companies back into the United States. And I want you to manufacture in the United States. We're going to be lowering taxes, we're going to be getting rid of regulations that are unnecessary.
Many people watching the chaotic rollout of Trump’s executive orders on immigration, his demands for investigations into phantom vote rigging, his mysterious ties to Russia, his financial conflicts of interest, and his bizarre lies about Inauguration Day crowd size have found themselves wondering why more Republicans don’t stand up to him.
This event with PhRMA lobbyists explains why. On most of the big public policy issues of the day, Trump is a very conventional Republican. And on those issues where he hasn’t been conventional, Republican Congress members and business executives feel confident they can turn him around. On some issues, they probably won’t. But on this issue, it seems like they did.
