by PharmacyChecker.com | Jun 7, 2011 | Drug Prices
In March of this year the FDA took the unusual step of allowing an “unapproved” compounded drug to remain on the market to explicitly make sure Americans could afford that product. That drug is hydroxyprogesterone caproate, branded by K-V Pharmaceuticals as Makena, the first FDA-approved drug to prevent the risk of preterm birth in certain women. Will more such government interventions continue in support of drug affordability?
According to the Wall Street Journal Blog,“Typically, whenever a drug is approved, pharmacy compounding isn’t allowed and the FDA acts to remove any unapproved drugs that might on be the U.S. market.” However, the FDA is allowing the compound to remain solely because of the outrageous cost for the brand-name product; Makena is priced at $1,500 per dose! Before Makena was approved, the same drug without the K-V branding and FDA stamp of approval cost between $10 – 20 per dose.
To the best of our knowledge, the FDA’s role does not include controlling prices to help Americans have access to the medication they need. However, that is precisely what the FDA did in the case of Makena. In our opinion, that’s also what the FDA does by not enforcing certain personal drug importation laws that, if enforced, would prevent Americans from affording needed medication. Currently, under its personal drug importation policy, the FDA has stated it does not take enforcement action against individuals who import non-controlled medicines, which are generally (and ironically) viewed as not FDA-approved even if they’re the exact same drug sold here, often due to labelling or pill color and shape differences between otherwise identical products. (more…)
Tagged with: Americans, Avanair Pharmaceuticals, Colcrys, Compound drugs, Drug Importation, FDA, FDA-approved, hydroxyprogesterone caproate, K-V Pharmaceuticals, lawmakers, Makena, non-controlled medicines, Not FDA-approved, Nuedexta, personal drug importation, Pharmaceutical Prices, policy, U.S. Government, URL Pharma, Wall Street Journal
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | May 31, 2011 | Drug Importation, Online Pharmacies
Last Thursday, the Senate Judiciary Committee unanimously passed S. 968, Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011, also known as the Protect IP Act. Its passage represents a real threat to Americans’ access to safe and affordable medications online and we hope that as the bill makes its way through the legislative process it will be amended appropriately.
Essentially, the bill will make it easier to crackdown on rogue pharmacy sites selling fake meds and not requiring a prescription, which is great; however, it will also encourage actions to block Americans’ access to reputable and affordable non-U.S. online pharmacies that sell genuine medication and require a prescription, which are a lifeline for uninsured Americans. That’s because of Section 5, which includes in its definition of “infringing sites” online pharmacies that sell medications to Americans that are not manufactured in a facility approved by the FDA. (more…)
Tagged with: Americans, Australia, Canada, cloture, Demand Progress, Electronic Frontier Foundation, Eli Lily, European Union, fake meds, FDA, First Amendment, GlaxoSmithKline, Google, legislation, Merck, Online Pharmacies, Pfizer, S.968, Senate Judiciary Committee, Senator Wyden, The Protect Intellectual Property Act, UK, United States
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Apr 15, 2011 | Drug Prices
Last month the U.S. Food and Drug Administration announced a no contest grant to be awarded to the National Consumers League (NCL) to examine the problem of prescription adherence. The problem is one we discuss almost every week on this blog: Americans are not taking their prescribed medication. Therefore, when we came across an FDA initiative aimed at tackling the problem we were intrigued.
In the FDA announcement we expected to find mention of some of the known causes for Americans not taking their prescribed medications, such as cost, which has previously been proven as the number one reason Americans skip prescriptions. Amazingly, there was not one mention of drug prices or cost in the announcement. In choosing NCL as the recipient of the $40,000 grant it appeared that FDA might be on the right track After all, NCL knows from its own commissioned study that drug prices are the main reason Americans don’t take their medications. NCL has brought together “stakeholders” from government, non-profit organizations and the private sector. This sounds like a good idea. (more…)
Tagged with: AARP, Canada, Drug Prices, FDA, National Consumer's League, National Medication Adherence Campaign, prescription adherence, prescriptions
