Generic drugs save 43 million Medicare recipients billions of dollars annually compared to the cost of their brand-name drugs and are typically sold at prices about 80% cheaper. However, if you think that all generics are the same in terms of side effects, manufacturing quality, price, etc Part D: Prescription Drug Coverageyou are wrong.
For this reason, it is important that you do your research before purchasing a generic drug and enrolling in a Medicare drug plan. Unfortunately it’s not easy.
Fearful of the generic drug problem her father had
Just ask Susan Jaquith, a retired teacher in Wilson, N.C., who had been paying about $2,000 a year for a brand-name blood pressure medication and wanted to switch to a cheaper generic. But she was nervous. Her late father developed severe bronchitis when he replaced the same medication with a generic one.
“My doctor said it was very likely I would have the same problem,” Jaquith said. “And he was actually right.”
After starting the generic, “I woke up with a deep cough in my chest,” Jaquith recalls. So she decided to look for another generic that didn’t have the same side effects.
Your research in the National Library of Medicine DailyMed.gov The website showed that some of the drug’s generic versions contained inactive ingredients while others did not.
After finally finding an alternative without potentially problematic ingredients and a pharmacy that could get her the generic, she ordered it. Since then, Jaquith has been taking the pill – without bronchitis – and has saved a lot of money.
“I pay maybe $200 a year for my generic blood pressure medication,” Jaquith said.
What can make similar generics different?
Their experience begs the question: How can two generics for the same brand-name drug be different? Finally, the Food and Drug Administration (FDA) says that generic drugs are “developed to be identical in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use to an already marketed brand-name drug.”
But generics can differ in two important ways.
One of these is what Jaquith has experienced: Some have inactive ingredients that generally aren’t a problem for people who take them, but can be a problem for people with allergies or sensitivities.
Another difference is where and how the generic was manufactured, which was the subject of Katherine Eban’s 2019 exposé on the generic drug industry. Bottle of lies.
Around a third of generics and almost half of the active ingredients in generics come from India and China. Eban noted that the FDA inspection process there can be problematic.
Concerns About FDA Inspections
“In the US, the FDA shows up unannounced and stays as long as necessary,” says Eban Assets. “Overseas, the FDA is invited to inspect, notifying companies doing so months in advance, creating a Potemkin village of compliance, cleaning up fake data, and destroying incriminating documents. “The entire system of overseas inspections is completely broken.”
Fortune contacted the FDA about the overseas inspections. A spokesperson said: “FDA uses risk-based approaches to identify foreign and domestic facilities for inspections and conducts both announced and unannounced inspections.” Announced inspections typically provide foreign facilities with up to 8-12 weeks notice . When warranted, FDA will conduct inspections abroad without notice to the facility, and we will continue to do so as necessary consistent with our risk-based inspection approach. We also conduct inspections with only 24 hours notice to the facility.”
Eban does not warn those with Medicare against taking it any generic. She takes the pills herself. “The question is how consumers can get high-quality generic drugs and how can the FDA guarantee their high quality?”
She is particularly concerned about foreign manufacturing of extended-release generic drugs, such as those for ADHD. “It can be very difficult to copy the time-release formula,” says Eban.
The transparency problem with generics
She’s angry that it’s so hard to know where generic drugs are made.
“You can stop by Whole Foods and find out where your apple came from and how many miles it traveled, but you can’t find out where your generics were made,” says Eban.
The name of the generic manufacturer, its headquarters and possible side effects are usually noted on the packaging, but not the place where the active ingredients and the finished product were manufactured. “This information is not available to consumers,” says Eban. “It is impossible.”
Almost.
Michael Sargent, senior director of policy at the Association for Accessible Medicines (the generic drug trade group), notes that there is a National Drug Code (NDC) number on the packages. It can tell you about the manufacturer and packer if you look up the number on the website FDA website.
But Sargent admits, “I don’t think most patients would immediately look at that number and say, ‘Okay, I’m going to query that NDC number and find out.'”
Encouraging news, says Eban: Pharmaceutical companies are increasingly making generic drugs in the U.S., where FDA oversight is stricter.
Here’s how to do your generic drug research
To learn more about generic medications and their potential side effects, Sargent and Eban recommend speaking to your pharmacist. Eban suggests not neglecting local pharmacies.
For practical research, there is the website Jaquith uses, DailyMed.gov, which contains information on over 148,000 drug package inserts, and the guide Eban created for her own website: “A Guide to Investigating Your Own Drugs.” You can see if there is a generic version of your brand-name drug in the Drugs@FDA section of the FDA website.
Eban is a fan of using the FDA’s website: “Orange book,” which allows you to search for generics by a drug’s name, active ingredients, or number and then see whether the agency has issued relevant warning letters.
She also recommends looking for an “authorized generic,” meaning it has been authorized by the brand company and is likely made with the same formula and ingredients.
What happens to the cost of generic drugs?
The prices for generic drugs can also fluctuate greatly and those with Medicare are limited.
Although the Average price of a generic drug According to the Congressional Budget Office, prescriptions covered by Medicare Part D plans are $17 and have fallen since 2009 for 12% of Medicare beneficiaries Have filled at least one generic prescription for more than $20 in 2022.
Part D insurers have increasingly moved generics from Medicare’s Tier 1 status (for the lowest-cost drugs) to Tier 3 (a mix of high-priced generics and the lowest-cost brand-name drugs).
“In 2011, 73% of generic drugs covered in Medicare Part D were classified as Tier 1, where costs are shared [by beneficiaries] averages zero. In 2021, this figure has fallen to 15%,” says Sargent.
The average outpatient costs According to health research firm KFF, the price of level 3 drugs is $42.
Many of the most expensive generics are not offered by disruptive direct-to-consumer startups like Mark Cuban’s Cost Plus Drugs or Amazonaccording to a year 2024 Study in the Journal of General Internal Medicine.
Additionally, some generic drugs are not covered by certain Part D plans, increasing costs for people who need them.
The Biden administration is working on one Pilot program This would create a Medicare program that caps cost-sharing at $2 per month for a 30-day supply of 150 major generic drugs (for chronic conditions such as high blood pressure) without prior authorization.
Advice for purchasing the Part D plan
When Medicare open enrollment for 2025 begins in October, experts advise taking advantage of it Plan Finder Tool on the Medicare website to compare the generic drug policies of the plans you are considering.
You want to see if a plan covers your generic medications and how much you’ll pay for them.
Remember that in 2025, there will be a $2,000 cap on prescriptions covered by a plan. This can help curb the cost of brand-name and generic drugs, Sargent says, because once you exceed the $2,000 threshold, the Plan D insurer has to pay the overage.