by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jul 23, 2014 | Drug Prices, Saving Money on Prescription Drugs, Specialty Drugs
Ever since the FDA approved Sovaldi (sofosbuvir), and its price was announced – $1,000 per pill – healthcare advocates, health insurance companies, pharmacy benefit managers, consumer groups, and politicians have been up in arms. Its cost, for the usual prescription of 84 pills, is about $31,000 more than the median annual household income in the United States, which is about $53,000. How could a 12-week drug treatment plan cost $84,000?! Well, the manufacturer of Sovaldi, Gilead Sciences, can charge whatever it wants since there is no equivalent brand drug or generic on the market and the U.S. government, by law, cannot legally negotiate drug prices for Medicare.
The costs to treat Hep C don’t stop with Sovaldi by the way. Depending on the genotype of a person’s Hep C, Sovaldi is prescribed as part of a medication cocktail that also includes either ribavirin or ribavirin and an Interferon treatment. Total prices for treatment can reach $160,000 but we’ll just focus on Sovaldi so as not to bite off more than we can chew.
This Twilight Zone approach to pricing Sovaldi and other specialty medications pumps up the rage volume to a frightening anti-pharma crescendo, but now a moment of silence: Thank you scientists, medical researchers, and dedicated people at Gilead for developing this truly awesome medication and bringing it to market. Sovaldi actually cures Hepatitis C, a disease that afflicts about 3.2 million Americans! Rock on Gilead! Gilead and its shareholders should and shall be rewarded handsomely.
Despite this, Gilead and the Big Pharma Gang should not be allowed to threaten the American healthcare system with obscene prices, even for their wonder drugs. Is Gilead really expecting to be paid $84,000 to treat 3.2 million people: a cost of $268 billion? That is more money than the gross national products of 150 countries! Finland’s annual economic output in 2013 was $257 billion. On to the dirty dollar details… (more…)
Tagged with: Gilead Sciences, Sovaldi, specialty drugs, Specialty Medications
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jul 18, 2014 | Controlled Drugs, Online Pharmacies, Rogue Online Pharmacies
In online pharmacy news, the major story today is that FedEx was indicted for distributing controlled prescription drugs for Internet pharmacies to people who did not have valid prescriptions. FedEx claims it is not guilty and that its indictment and potential prosecution threaten a key principle of its business ethics and federal law: don’t open the mail. FedEx also says that for years they have asked the DEA for a list of targeted illegal online pharmacies but have not received one and that it cannot be expected to act as a law enforcement agency. The U.S. Department of Justice alleges that FedEx specifically “conspired” with two online pharmacies selling controlled drugs without proper prescriptions.
I’m departing from this media hot topic (better you read it in Bloomberg, USA Today, etc) to give you some backstory on controlled drugs and Internet sales. Our blog’s usual focus is on consumers seeking non-controlled prescription drugs online, and the PharmacyChecker.com Verification bans online pharmacies that sell controlled without a valid prescription, and all international online pharmacies that sell controlled drugs into the U.S. However, some Americans try to obtain prescription narcotics and other controlled drugs without a prescription online, which can turn out deadly. (more…)
Tagged with: DEA, FedEx, Prescription Narcotic, Ryan Haight
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jul 10, 2014 | Drug Importation, Online Pharmacies, Politics
In our recent public comments to the U.S. Food and Drug administration, we invoked your concerns with new FDA regulations to implement Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA) for destroying safe (and affordable) medications imported for personal use. We issued a press release on the issue as well. Here are three of almost 2000 comments:
Morton Ross, Palm Harbor, FL 2014-04-03, “The Meds I take daily, are the difference between ‘Life and Death’. I cannot afford the higher prices at local pharmacies.”
Darilyn Schlie, Fort Worth, TX 2014-04-03, “Without the ability to go outside the US, I will not be able to afford the medication I need.”
James Marshall, Nashville, TN 2014-04-03, “I have emphysema and could not afford my medications if not for being able to order some of them from outside the USA.”
We need more voices! Working with RxRights.org, you can send a message to the Secretary of Health and Human Services stating your concerns, asking that she prevent morally unjust and dangerous refusals and destructions of imported drugs for personal use. The messaging process is easy and together we can win this!
The situation is not dire…yet. The regulation has not taken effect and it’s uncertain what its impact will actually be. Currently, the conventional wisdom holds that the chances of your prescription order being detained by U.S. Customs is less than 1%. What we don’t know is if the new regulations will change that dramatically.
What we do know is that FDA issued a proposed rule in May to implement Section 708, which is deceptively called “Destruction of Adulterated, Misbranded, or Counterfeit Drugs Offered for Import.” Destroying adulterated and counterfeit drugs sounds like a good plan but many, if not most, ‘misbranded drugs’ sold in foreign pharmacies are actually the same drugs you can buy at your local pharmacy just with different labeling and packaging. Though sometimes manufactured in a plant not registered with the FDA, they are manufactured in plants registered with another drug regulatory authority. Or they might be a generic version of a brand name drug that is approved in the U.S. but not yet off-patent here. These examples of real, safe and effective medications are usually deemed ‘misbranded’ or ‘unapproved’ by FDA. For more on this see my New York Times op-ed.
To Congress’ credit, before Section 708 goes into effect, regulations must be drafted requiring that consumers, 1) receive notification that their prescription drug orders have been refused import and 2) are provided “appropriate due process” to defend their drug imports before they are destroyed. Unfortunately, as I read it, FDA’s proposed rule did not assure consumers “appropriate” due process. In our comments we proposed that FDA clearly explain to consumers why their drug imports were refused and exactly how consumers can provide testimony to prevent the FDA from destroying their imported drugs. In the final rule, consumers should be able to successfully defend refused drug imports of safe and prescribed medication to have them released not destroyed. They need those medications to safeguard their health, and sometimes even lives.
We also proposed a revision to FDA’s personal drug importation policy so that safe personally imported medication from certain countries with very strong pharmaceutical regulations and pharmacy standards would not be detained or refused. We also recommended continuing actions to shutdown dangerous rouge pharmacy sites but not obtusely conflating them with safe international online pharmacies.
See below to learn more and advocate.
Petition the Government!
Comments by Americans concerned with Section 708
Comments by PharmacyChecker.com to the FDA on Section 708
