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News
Editors Note: Due to a very large amount of news in pharmacy this week, this section is longer than usual.
FDA Contract to ASHP To Develop Standardized Concentrations For IV And Oral Drugs.
The American Society of Health-System Pharmacists (ASHP) has received a three-year contract as part of its Safe Use Initiative to develop and implement national standardized concentrations for intravenous (IV) and oral liquid medications. Medication errors involving IV and oral liquid medications are especially prevalent during transitions of care and hospitals must do more to prevent medication errors, estimated to harm at least 1.5 million patients annually. ASHP plans to present the FDA with final standardized lists for adult-based IV continuous infusions (including drug concentrations and associated dosage units) and for compounded oral liquid medications (drug concentration) by March 30, 2016.
http://drugtopics.modernmedicine.com/drug-topics/news/ashp-develop-iv-and-oral-drug-standardized-concentrations
Turing Pharmaceuticals CEO Agrees To Lower Price Of Drug After "Widespread Outrage" Over Price Increase.
Media sources report that Turing Pharmaceuticals CEO Martin Shkreli announced that his company has agreed to lower the price of its drug, Daraprim (pyrimethamine), after it had increased the price from $13.50 to $750 per tablet in 24 hours. Shkreli said on ABC World News (9/22, story 8, 1:25, Muir) "We've agreed to lower the price of Daraprim to a point that is more affordable is able to allow the company to make a profit, a small profit and we think the changes will be welcomed."
Shkreli, a 32-year old former hedge fund manager, says that he raised the price of the drug to fund research to develop other medicines, adding "I'm a capitalist. I'm trying to create a big drug company, a successful drug company, a profitable drug company."
The Washington Post (9/23, Cha) reports that although Shkreli has announced that Turing will reduce the price, he "did not commit to a specific price."
http://mailview.bulletinhealthcare.com/mailview.aspx?m=2015092301ashp&r=3276068-1c1e#S1
Little-Known FDA Program is Driving Drug Prices Higher
As the nation has been focused on the depredations of Turing Pharmaceuticals, its CEO Martin Shkreli and his decision to jack up the price of an important drug by 5,000%, not enough is being said about the other factors contributing to America's sky-high prescription drug costs.
The high costs of market-exclusivity falls primarily on the patients who are given prescriptions for the drug. We are talking about the FDA's "Unapproved-Drugs Initiative" that was launched in 2006. The program is well known to pharmacists and physicians who blame it for huge increases in the price of drugs that have been in common use for decades (and even, in one case, for millennia). Thanks at least partially to the FDA program, the price of vasopressin, has risen 10-fold. Neostigmine has gone from less than $5 to $90. But, the worst case is that of colchicine, which was first used to treat gout 3,000 years ago and has been in generic use in the U.S. since the 1800s. It's price (Colcrys) rose 50-fold. Generally, the new manufacturers had done little to alter, much less improve, the traditional drugs before claiming FDA-mandated exclusivity periods ranging from three to seven years.
But federal law also allows the FDA to incentivize drug research and development by granting marketing exclusivity to manufacturers who demonstrate a new use for a drug, or even a new dosing regime. If the new indication applies to an "orphan" condition suffered by a small number of patients, the exclusivity period can be seven years.
The FDA says such price increases are beyond its jurisdiction, as it is not expected to take price into account when regulating a drug.
The industry's biggest price gougers
Following Turing Pharmaceuticals' proposed 5,000% price hike for the toxoplasmosis drug Daraprim the PHARMA companies have been very quiet. It might be that some in the industry have a neat scapegoat in Turing, all the while hiking drug costs in its own right. An analysis, from EvaluatePharma's sales and volume pricing module, consists of more than 30,000 Medicaid-covered drugs for which US pharmacy acquisition cost data are compiled weekly. The following tables provide a good indication of where companies have, for various reasons, hiked prices of drugs that address far bigger indications than Turing's, posing a greater burden on payers.
| Drugs with no US generic availability |
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| Drug | Company | Price increase* |
|---|
| Dutoprol | AstraZeneca | 928% |
| Sprix | Egalet | 479% |
| Zelapar | Valeant | 242% |
| Treximet | GlaxoSmithKline | 149% |
| Fanapt | Vanda | 117% |
| Riomet | Sun Pharmaceutical | 103% |
| Ertaczo | Valeant | 79% |
| Duexis | Horizon Pharma | 75% |
| Noritate | Valeant | 66% |
| CombiPatch | Noven | 65% |
| *Pharmacy acquisition cost, Q2 2015 vs Q2 2014. |
| Drugs with generics available |
|---|
| Drug | Company | Price increase* |
|---|
| Zonegran | Eisai | 387% |
| Tasmar | Valeant | 346% |
| Vandazole | Upsher-Smith | 309% |
| Carac | Valeant | 200% |
| Wellbutrin XL | Valeant | 143% |
| Cardizem CD | Valeant | 130% |
| Verapamil HCl | Pfizer | 121% |
| Betapace | Bayer/Bristol-Myers Squibb | 105% |
| Ultravate X | Sun Pharmaceutical | 101% |
| Paxil CR | GlaxoSmithKline | 86% |
| *Pharmacy acquisition cost, Q2 2015 vs Q2 2014. |
| Generic drugs |
|---|
| Drug | Company | Price increase* |
|---|
| Econazole nitrate | Taro/IGI Laboratories | 991% |
| Propranolol HCl | Ipca Laboratories | 891% |
| Amitriptyline HCl | Endo | 647% |
| Allopurinol | Endo | 505% |
| Clobetasol propionate | Wockhardt | 451% |
| Ofloxacin | Akorn/Valeant | 419% |
| Methylphenidate HCl | Mallinckrodt | 403% |
| Ursodiol | Epic/Lannett | 399% |
| Sulfamethoxazole & trimethoprim | Akorn | 354% |
| Nicardipine HCl | Epic Pharma | 338% |
| *Pharmacy acquisition cost, Q2 2015 vs Q2 2014. |
http://epvantage.com/Universal/View.aspx?type=Story
&id=596784&isEPVantage=yes
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