Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Only Old Drugs That Don't Need Safety Tests Get Studied & Win Monopoly Status from FDA

Only Old Drugs That Don't Need Safety Tests Get Studied & Win Monopoly Status from FDA | Pharmaguy's Insights Into Drug Industry News |
Colchicine, a gout remedy so old that the ancient Greeks knew about its effects, used to cost about 25 cents per pill in the U.S. Then in 2010 its price suddenly jumped 2,000 percent.

That’s just one of the side effects of a U.S. Food and Drug Administration plan to encourage testing of medicines that have been around longer than the modern FDA itself, and so have never gotten formal approval.  Companies that do the tests are rewarded with licenses that can temporarily give them monopoly pricing power as most rivals are eased or kicked off the market. The result has been a surge in the cost of drugs used in treatments from anesthesia to heart surgery and eye operations.

It can bring big paydays for the producers. URL Pharma, the small Philadelphia drugmaker granted rights over colchicine, was bought for $800 million by Takeda Pharmaceutical Co. in 2012. Asia’s biggest drugmaker has since brought in $1.2 billion in revenue from the branded drug, Colcrys, which went on the market at a wholesale price of almost $6 a pill. Takeda says testing for FDA approval made the drug safer.

But patients and hospitals are feeling the pinch, and politicians have begun to notice. Hillary Clinton’s recent promise to address the issue sent pharmaceutical stocks plunging. Critics say the FDA plan lets entrepreneurs make windfall profits on drugs where there was never much concern about safety or efficacy.

In many cases, the program “almost had the opposite effect as intended,” said Joseph Biskupiak, a professor at the University of Utah College of Pharmacy. “The only drugs that got studied are the ones that don’t have a problem.”

The FDA’s rationale is that some drugs have never been measured against modern safety standards. The program “has been a success” that has removed dangerous drugs from the market, said Michael Levy, deputy director in the compliance office of the FDA’s drug evaluation unit.

The agency acknowledges that approving branded versions of old generic drugs may make them more expensive when a sole manufacturer remains to make a medication, but says that’s outside its remit. “FDA does not regulate according to economic factors, nor do we have control over drug pricing,” spokesman Christopher Kelly said.

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The Case of Brand Colcrys vs. Generic colchicine: Santa Claus (i.e., consumers) Pays the Price

The Case of Brand Colcrys vs. Generic colchicine: Santa Claus (i.e., consumers) Pays the Price | Pharmaguy's Insights Into Drug Industry News |

Six years ago, the FDA approved a drug called Colcrys to treat acute gout attacks and familial Mediterranean fever, an inherited inflammatory disorder. The move came as part of an agency initiative to regulate dozens of medicines that had never been formally approved, but were on the market when the FDA received authority to oversee the drug approval process.

In this instance, Colcrys was the brand name given colchicine, which was sold for decades by several companies and cost 9 cents a pill. URL Pharma won FDA approval – and seven years of marketing exclusivity – by running a small study that gauged the effectiveness of different dosages. URL sued other colchicine makers and, by early 2011, marketing exclusivity took hold. And Colcrys cost $5 a pill.

Now, a new study says the approval was not worth the effort, at least for patients. Harvard Medical School researchers examined nearly 217,000 enrollees in an insurance database who were diagnosed with gout or FMF before and after marketing exclusivity kicked in. Here is what they found:

The likelihood of receiving a prescription for either colchicine or Colcrys to treat either malady dropped during the year after the marketing exclusivity took hold – 0.5% per month for gout sufferers and 7.6% for patients with FMF. Meanwhile, prescription costs and related health care costs for gout and FMF patients rose during the same period, by 55% and 38%, respectively, according to the study.

“This shows that this type of incentive can go wrong,” says Aaron Kesselheim, a study co-author and an associate professor of medicine at Harvard Medical School. “The market exclusivity was granted for behavior that didn’t provide much public health benefit. But it caused the price to go up, increased spending by patients and reduced use of the drug, which has potentially bad public health implications.”

The findings follow substantial criticism that was leveled at the FDA not long after the approval led to the price hike, since Colcrys was not a new drug.

Pharma Guy's insight:

This just confirms what I wrote about back in July, 2011, in a blog post:

"URL Pharma's War against "generic" colchicine was recently in the news when it was discovered that its attorneys sent threatening letters to doctors who were prescribing "generic" colchicine. Some doctors had advocated use of a cheaper version of the drug, whose active ingredient is colchicine. In response, URL Pharma's general counsel sent letters to several of the critics asking them to "clarify the record" and saying there were "potential risks and liability" associated with using unapproved versions (see "Pharma Company Sends Letters to Docs Who Criticized Drug Online").

Not only doctors are complaining about this, so are patients. I recently received this letter from a reader:

"This colchicine thing is just the beginning of wiping out low price and low profit generic drugs. Preparation H could be next!

"How is it that – as you can see from my CVS receipt in January, the cost for 60 colchicine pills (one month’s supply) was $27.80 - $8 paid by me and $19.80 paid by my Part D Medicare insurance. This has been the cost ballpark for the 10 years or so that I have been taking colchicine. (My copay under Part D is 20%, so I should have paid $5.56, but I have an $8.00 minimum copay).

"But then something happened, and all of a sudden, colchicine became a “new” super drug, even though it’s been around since the days of the Roman Empire. It is now called Colcrys, and you can see from my May receipt that my 20% copayment under Part D was $51.43, meaning that the full price is now $257.15."

For more on that, see here: 

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