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
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
As the retrial of former Governor Rod Blagojevich on corruption charges commences, we’d like to re-direct your attention to the personal drug importation program he championed. Had that program received better backing from our politicians, fewer Americans would have gone without needed medications.
In October of 2004, a personal drug importation program called I-Save Rx was launched under the leadership of Blagojevich and then Congressman Rahm Immanuel. The lead pharmacist responsible for the program’s development was Ram Kamath, PharmD, now Director of Pharmacy Policy and International Verifications for PharmacyChecker.com. I-Save Rx showed state residents how to access affordable medication from approved pharmacies in Canada, the United Kingdom and Ireland. Within just seven months, Wisconsin, Missouri, Kansas and Vermont had joined the initiative, allowing their residents to participate as well.
Unfortunately, after its approval, the government did not market the I-Save Rx program and it suffered due a lack of political will. But I-Save Rx’s creation proved that government could, without much difficulty, create a program to facilitate the purchase of affordable medication from Canada and other countries. In fact, our current Secretary of Health and Human Services, Kathleen Sebelius, was governor of Kansas when she approved the program for use by her state’s residents. It should speak volumes that the administration official now tasked by President Obama with “protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves” approved of a personal drug importation program and made it available to the residents of Kansas. (more…)
Tagged with: Americans, Blagojevich, Canada, Dr. Ram Kamath, Drug Importation, Health Secretary, I-Save RX, Ireland, Kansas, Kathleen Sebelius, Missouri, President Obama, public health, Rahm Immanuel, Retrial, United Kingdom, United States, Vermont, Wisconsin