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? The more knowledgeable you and your doctor are about medications the better. A co-author of the study, Dr. Sidney Wolfe, founder of Public Citizen, say’s: “Doctors need to know in real terms, is this a breakthrough drug or not.” Essentially, if a new drug is not a game-changer over an old drug to treat a given condition then stick with the old drug. The study also found that prescribers do not have a necessary single information source to consult on this critical matter and one ought to be made available ASAP.
If you want to know more but not read the entire study then read a summary on Medscape.
Time to talk about drug costs! If your healthcare practitioner prescribes you a new-to-market drug that is not available as a generic, then I recommend asking him or her if there are therapeutically equivalent drugs which could work just as well.
For instance, when it comes to Selective Serotonin Reuptake Inhibitors (SSRIs), the most popular class of drugs that treat depression, experts often say that the newer ones do not provide breakthrough therapeutic benefits. Prozac, Zoloft, and Lexapro, which are very popular SSRIs, are all now generic and usually very inexpensive. If the experts are correct, then there is usually no reason to buy newer versions of SSRIs. And yet they keep coming! A new SSRI, just approved by the FDA, called Brintellix, is $316 for a one month supply at a Walgreens in New York City. At that same pharmacy you can buy generic Prozac, called Fluoxetine, for $23.99 – 92% less!
One of the most widely prescribed classes of medications are statins. Statins can reduce cholesterol and help prevent heart attacks. The most popular of these drugs for many years was Lipitor. Lipitor is now available as generic atorvastatin. A newer statin that is not available as a generic in the U.S. is Crestor. A one month supply of Crestor at the Walgreens mentioned above is $243.99; for atorvastatin it’s $154.99. Those are lousy prices for atorvastatin and Crestor. The woman I spoke with said that with a Walgreens card (which costs about $20-$25 to obtain) I could buy the Crestor for $207 and the Atorvastatin for $64.99. As explained below, those prices are still way too high and you can avoid them.
These prices are of course for people paying out of pocket and most people have health insurance. Even if you’re insured, the co-payments will vary for these same drugs; the newer drugs will almost always have much higher co-pays than the older ones.
If you really are one of the millions of Americans paying out of pocket, those Walgreens prices above are awful. Prices vary a lot pharmacy to pharmacy. At a Costco Pharmacy in Queens, atorvastatin (20mg, 30 pills) is only $15.59! For Fluoxetine, the price quoted was $6.10! These are better than the online pharmacy prices you can find on PharmacyChecker.com’s price comparison pages! The lowest prices on Crestor are available from international online pharmacies. One online pharmacy approved in the PharmacyChecker program sells a one month supply of Crestor 10mg for $37, compared to $207 at Walgreens – a savings of $170 per month. Unlike Crestor, Brintillex cannot be found from a PharmacyChecker.com-approved international online pharmacy.
The wrench in this story is that for some people, Brintellix and Crestor may work better than Fluoxetine and Atorvastatin, respectively. Those generics are not bioequivalent (meaning the exact same, according to the FDA).They are therapeutically equivalent, which means they help patients reach similar treatment goals using a similar pharmaceutical mechanism. For a variety of reasons certain SSRIs and statins work better for some people than others as is the case for other classes of drugs where consumers have many options. In those cases, which are infrequent, newer is better, so you better shop around.Tagged with: Atorvastatin, Brintellix, Crestor, Prozac, SSRI, Statin