by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Aug 15, 2014 | Drug Prices, Drug Safety, FDA, Generic drugs, New Drugs
Most people think newer is better, but according to a study published in Health Affairs that might not be the case for prescription drugs. In short, the new study shows that drugs approved by the U.S. Food and Drug Administration after enactment of the Prescription Drug User Fee Act of 1992 (PDUFA), a bill that led to more expeditious drug approvals funded by drug companies, were more likely to have safety problems than ones approved before PDUFA. These findings are not only relevant to drug safety, but also to drug savings. Older drugs are often sold as generics and, thus, will have much lower co-payments than new drugs. For those paying out-of-pocket, the cost of a generic is often 80% less than the brand.
The study analyzed 748 drug approvals between 1975 and 2009. The approvals were of new molecular entities not for generic versions of existing brand-name drugs. Before PDUFA the chances that safety issues would arise involving approved new drugs was 21.2%; after PDUFA it increased to 26.7%.
According to the lead author, “The FDA needs to make sure drugs are safe before they’re approved, not rush to judgment in order to meet artificial deadlines.” Not surprisingly, FDA and the Pharmaceutical Researchers and Manufacturers of America, take issue with the study. Their main points are that PDUFA helped speed up important drug approvals and get medications to patients faster and it improved the predictability of FDA’s system of drug approvals.
Regulations for marketing and manufacturing new drugs can save people and they can kill people. If the regulations are too rigid then patients won’t get needed medications fast enough. Or regulations can increase manufacturing costs resulting in unaffordable drug prices. If regulations are too weak then drugs will be less safe and effective. While in my opinion the study clearly has merit, PDUFA is helpful. Before its passage, drug approvals were lagging far behind other advanced economies in Europe.
Furthermore, the study does not show “causality,” meaning it does not prove that faster drug approvals after PDUFA led to less safer drugs. Nonetheless, it’s understandable that a drug with a long history of safe and effective use, accompanied by few side effects, is more trustworthy than a newly approved drug since the long term effects of the latter are unknown.
But what does this all mean for consumers and drug savings? (more…)
Tagged with: Atorvastatin, Brintellix, Crestor, Prozac, SSRI, Statin
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jun 25, 2014 | Drug Prices, Drug Safety, Generic drugs
Toprol XL, a prescription drug that treats high blood pressure and is shown to lower the risk of heart attacks, is in the news due to recalls of some generic versions and because some doctors are finding the generics doesn’t always work as well as the brand. Consumers taking a generic version (metoprolol succinate extended-release), might want to switch back to the brand, but that could raise their drug bills substantially
The issue has also re-ignited the topic of problems with Indian drug quality. Wockhardt and Dr. Reddy’s Laboratories, both based in India, have pulled 100,000 bottles of their respective metoprolol succinate extended-release products because their pills were not dissolving properly. For extended release drugs, this can be a big problem with a drug’s efficacy.
So where can you buy an American made version of this drug? I believe that would be very hard to do. Brand name Toprol XL sold on U.S. pharmacy shelves is a product of Swedish company AstraZeneca and, according to the drug’s labeling, made in India. There are American companies that make metoprolol succinate as well, such as Mylan, but they manufacture the drug in India, too. Some Toprol XL generics were made in America, but that didn’t work out so well due to manufacturing problems here at home.
Dollars and Sense – You can save 70% on the brand!
In the U.S., generic metoprolol succinate costs about 45 cents a pill. If you want brand name Toprol XL (100mg), the cost is about $2 apill. However, if you only want the brand name product and want to spend a lot less, it can be purchased from a verified international online pharmacy for as little as 60 cents a pill, just a bit more than the cost of a generic in the U.S., and a 70% savings on the U.S. brand price.
Compare Toprol XL drug prices on all strengths on PharmacyChecker.com.
Tagged with: AstraZeneca, Dr. Reddy's Labratories, Toprol XL, Wockhardt
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Apr 25, 2014 | Advocacy, Drug Importation, Drug Safety
While it’s a life (and wallet) saver for millions of Americans, it seems to me that safe personal drug importation is an inconvenient truth for the U.S. Food and Drug Administration. A couple of weeks ago, The New York Times published a Letter to the Editor, “Unsafe Foreign Drugs,” by FDA Deputy Commissioner Howard Sklamberg as a response to my op-ed. His letter didn’t refute the gist of my position: the FDA and other regulators should not scare Americans or fool policymakers into believing that genuine medications purchased by Americans from licensed pharmacies in Canada and other countries are as dangerous as counterfeit drugs.
Mr. Sklamberg wrote, “Gabriel Levitt criticizes the Food and Drug Administration’s position that unapproved foreign drugs pose the same health risks as counterfeit drugs.” In fact, I do more than criticize FDA’s position. Their position is false and illogical. When FDA talks about “foreign unapproved drugs,” it often means real medication available in foreign pharmacies. That medication is either exactly the same as the medication sold here or a foreign version with the same active ingredients as medication sold here. When FDA talks about “counterfeit drugs,” they generally mean fake medication: products sold by criminals that fool people into believing that they were manufactured legally. In other words, it’s medication not licensed for sale in any country because the manufacturers – “counterfeiters” – were not authorized by any regulatory authority to make the drug. Real medication that is made under good manufactured practices and properly prescribed to a patient is almost always safe and effective. Fake (counterfeit) medication is almost never safe. For those reasons, claiming that drugs sold from pharmacies in other countries are as dangerous as counterfeit drugs is ridiculous.
Mr. Sklamberg cites the National Association of Boards of Pharmacy’s (NABP) data that only “3 percent of online pharmacies appear to meet state and federal laws” to show that most drug-selling websites are dangerous. What he doesn’t tell you is that the 97% of online pharmacies which fall outside this scope includes safe pharmacies, for example, licensed Canadian pharmacies in Manitoba that sell to Americans – in conformity with all Canada’s laws and rules. The NABP considers these “rogue” online pharmacies. Since the NABP represents U.S. boards of pharmacy, which are in turn heavily self-regulated by U.S. pharmacy interests, referring to all lower cost non-U.S. online pharmacies that sell to Americans as “rogue” appears commercially motivated. Furthermore, NABP takes considerable funding from drug companies for programs related to Internet pharmacy regulation and consumer communications, which also casts doubt on their independence.
Mr. Sklamberg writes: “Many sellers of unapproved foreign drugs falsely represent that they are from Canada to give the illusion that consumers are getting the same drugs approved for use in Canada.” That’s true; it is a problem, but that doesn’t mean there aren’t exceedingly safe non-U.S. online pharmacies. As we’ve explained on this blog, there are reputable Canadian pharmacies that have partnered with licensed pharmacies in other countries. Compare that to fake “Canadian” online pharmacies that publish the maple leaf and wave the Canadian flag. These are unethical, unsafe, and unrepentant operators often located in Russia and Eastern Europe. The NABP conflates the two kinds of websites, strikingly similar to FDA’s conflation of foreign, but “real,” medications with counterfeit drugs. If you want to find ones selling real medication, pursuant to a real prescription, dispensed by real licensed pharmacists, look for PharmacyChecker.com verified online pharmacies at http://www.pharmacychecker.com/online-pharmacy-ratings.asp.
What consumers want and need is real information on which online pharmacies sell genuine prescription drugs, dispensed safely by licensed pharmacists, for the lowest prices. That’s why Americans who choose to order outside the U.S. benefit from the information provided by PharmacyChecker.com.
To his defense, Mr. Sklamberg is an employee of the FDA and therefore is in the service of a bad law that restricts Americans from buying lower cost medications internationally. Hopefully he decides the best course for the public health is to encourage his agency to use its regulatory discretion to expand access to affordable medication internationally. FDA has considerable regulatory flexibility to do so.
And perhaps FDA is listening. My op-ed cited a particularly concerning provision of U.S. law, Section 708 of the Food and Drug Safety and Innovation Act, which facilitates the ability of regulators to destroy personally imported medication. Section 708 cannot go into effect until regulations are drafted and available for public comment on the due process provided to Americans whose medication orders are seized. The FDA’s website identifies April 18th as the date it planned to publish the regulations, and that date has come and gone with no sign of their publication!
Maybe the FDA’s delay is due to the 8,000+ Americans who petitioned them to make sure those regulations don’t impede their access to prescribed medications. I’ll leave you with a few comments posted to that petition explaining why Americans depend on safe personal drug importation and should have access to it:
CT Robertsson Jr — DENTON, TX
I am 72 yrs old, take several medications, and am likely to need others in the future. The price for some of my current drugs is criminal. Americans should cease being the personal property of drug companies who have billions to spend on political influence. If we’re all about “freedom” and “competition”, then let’s act like it.
Barbara Simpson — MCKINNEY, TX
I cannot afford my medications at the price American Pharmacies charge. If I am unable to obtain them from Canada at a much lower price it will mean I will have to go without my medications.
Ellen Renee Dill — SMYRNA, GA
I am on a fixed income. My insurance doesn’t cover every drug prescribed.
Michael Catalanello — PONCHATOULA, LA
It’s a freedom issue.
Tagged with: Howard Sklamberg, NABP, New York Times
by Gabriel Levitt, Vice President, PharmacyChecker.com and Sam Werbalowsky, Pharmacychecker.com | Nov 12, 2013 | Drug Safety, Online Pharmacies
“Is it safe to order prescription drugs from online pharmacies in Canada?”
Since prescription drug prices are much lower in Canada and other countries than in the U.S., Americans frequently ask this question. The New York Times’ Well Blog provides a simple and well-written answer that helps consumers find safe international online pharmacies that require a prescription and protect your privacy.
The answer to the question is, of course, yes, as long as the medications are regulated and dispensed from licensed pharmacies. The article “Ask Well: Buying Cheaper Drugs Online” notes that there are thousands of rogue sites pretending to be safe Canadian pharmacies. To avoid these rogue sites, simply shop from credentialed online pharmacies, including those listed on PharmacyChecker.com.
Tagged with: New York Times, Well Blog
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Sep 25, 2013 | Drug Safety
Drug safety topics on this blog usually relate to online pharmacies and the dangers posed by rogue sites selling bad meds or real prescription meds sold online but without requiring your prescription; and personal drug importation and the importance of only buying from credentialed online pharmacies. Today I read about the many deaths caused by overdoses of acetaminophen, a popular over-the-counter (OTC) pain-reliever, and felt moved to remind our readers to use great care when taking all medication. Whether or not a drug requires a prescription, in protection of your health, you are responsible for taking medicine as directed, whether by your doctor or on the label of an OTC product.
ProPublica, a non-profit investigative media organization, reported that over 1,500 Americans had died over the past decade from ingesting acetaminophen, usually because they took more than the recommended amounts. Their research is highly critical of the U.S. Food and Drug Administration for moving too slowly to safeguard American from taking too much acetaminophen, whereas other countries have done a much better job. McNeil Consumer Healthcare, a division of Johnson and Johnson, the makers of Tylenol, which is a leading brand of acetaminophen, is also criticized by ProPublica for hiding research about the medication’s dangers. This is not a criticism of the medication acetaminophen, as ProPublica is clear to point out its benefits and that many medical professionals stand by it – and for good reasons, it helps adults and children reduce their fevers and feel better.
Central to ProPublica’s criticisms is that the medication’s warnings do not include death as a side-effect of taking slightly more than the recommended doses. This is all the more important since studies show that other pain-relievers and fever-reducers, such as Ibuprofen do not cause death at such high rates.
People have sued McNeil and lost because their loved ones who died took more than the recommended dose of Tylenol. The parents of one child who died argued that the label did not warn that death could occur. Our hearts go out in abundance to these parents. To avoid such tragedies, the most important reminder here is that drug safety is often about following directions and is often a matter of life or death.
Tagged with: acetaminophen, OTC, propublica
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Feb 13, 2013 | Drug Importation, Drug Safety, Online Pharmacies
A report on drug safety published today by the Institute of Medicine (IOM) identifies important threats to the public health from falsified and substandard drugs but seems to ignore the facts about online pharmacy safety and savings. IOM’s report, “Countering the Problems of Falsified and Substandard Drugs,” which is funded by the FDA, wrongly concludes: “Trustworthy, accredited online drug stores do not sell medicine more cheaply than any other registered pharmacy would. Steep online discounts attract customers, but come from illegitimate vendors.” This conclusion is contradicted by a study in the References section of IOM’s report. That study is called “Unveiling the Mystery of Online Pharmacies: An Audit Study” and it’s published by the National Bureau of Economic Research (NBER). The NBER study is clear that Americans achieve safety and huge savings when buying genuine medication ordered online from registered non-U.S. pharmacies approved by PharmacyChecker.com. Therefore, trustworthy online pharmacies, in fact, do offer much lower drug prices; they are, however, not based in the United States.
As we see it, the IOM’s report reflects the position of its funding source, the FDA, when it comes to online pharmacies. We believe that the FDA essentially allows but prefers to ignore safe personal drug importation in its consumer awareness campaigns. Tens of millions of Americans forgo taking medication each year due to high domestic prescription costs, according to the Commonwealth Fund. It’s common sense that discouraging consumers from buying more affordable and safe medication online just because the pharmacy is outside the country will lead to fewer Americans getting the medications they need. That’s because, as a CVS/Caremark study shows, high medication costs are the number one reason Americans skip their meds.
Like the FDA, the IOM report recommends that Americans only use online pharmacies approved by the National Association of Boards of Pharmacy’s Verified Internet Pharmacy Practice Sites (VIPPS) program. The main safety criteria for a VIPPS-approved online pharmacy are that its dispensing pharmacies are licensed, inspected by their governing regulatory authorities, and require prescriptions. PharmacyChecker.com-approved online pharmacies meet those standards, which are verified for U.S. or qualified foreign pharmacies. VIPPS-approved online pharmacies cannot help Americans afford needed prescribed medication on many brand name drugs because their prices are much higher than licensed non-U.S. pharmacies. Furthermore, the NABP’s Internet pharmacy programs receive funding from pharmaceutical companies, such as Pfizer, who don’t want Americans buying their medication at lower foreign prices, which could make one question NABP’s independence…
Tagged with: Drug Safety Report, Institute of Medicine, NBER
