Generic drugs save Medicare's 43 million beneficiaries billions of dollars annually compared to the cost of their brand-name counterparts, and are typically sold for about 80% less. But if you think that all generic drugs are the same regarding side effects, manufacturing quality, price, and Part D prescription drug coverage, you are wrong.
That's why it's important to do your research before purchasing a generic drug and enrolling in a Medicare drug plan. Unfortunately, it's not easy.
Fearing the generic drug problem her father was suffering from
Just ask Susan Jaquith, a retired teacher in Wilson, North Carolina, who was paying about $2,000 a year for a brand-name blood pressure medication and wanted to switch to a less expensive generic. But she was nervous. Her late father developed severe bronchitis when he replaced the same medication with generic medications.
“My doctor said it was very likely I would have the same problem,” Jaquith said. “And he was actually right.”
After she began general treatment, “I woke up with a deep chest cough,” Jaquith recalls. So, I decided to look for a different generic drug that didn't have the same side effect.
Search it in the National Library of Medicine Daily Med.Gov The site showed that some generic medications come with inactive ingredients and others do not.
After finally finding an alternative that didn't contain potentially problematic ingredients and a pharmacy that could get this generic medication for her, she ordered it. Jaquith has been taking birth control pills ever since, and has not had bronchitis, saving a pack of them.
“I probably pay $200 a year for generic blood pressure medication,” Jaquith said.
What could make similar medications different
Her experience raises the question: How can two drugs with the same brand be different? After all, the FDA says that generic drugs “are created to be identical to an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.”
But generic drugs can be different in two important ways.
One is what Jaquith tested: some contain inactive ingredients which are generally not a problem for people taking them but can be for people with allergies or sensitivities.
Another difference is where and how the generic drug is manufactured, which was the subject of Catherine Eban's 2019 Generic Industry Presentation. A bottle of lies.
on One-third of generic drugs and nearly half of the active ingredients in generic drugs They are from India and China. Eban found that the FDA inspection process may be problematic.
Concerns about FDA inspections
“In the United States, the FDA appears unannounced and stays as long as it is needed,” Eban says. luck. “Abroad, the FDA is called in to conduct inspections, give months’ advance notice to companies that enter, set up a Potemkin compliance village, clean up fake data, and shred incriminating documents. The entire foreign inspection system is completely broken.”
Fortune has reached out to the FDA about third-party inspections. An FDA spokesperson said: “The FDA uses risk-based methods to identify foreign and domestic facilities for inspection and conducts announced and unannounced inspections. For announced inspections, foreign facilities are typically provided with advance notice of up to 8-12 weeks.” When necessary, the FDA conducts foreign inspections with little or no 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 24 hours notice to the facility Just.
EBAN does not warn Medicare beneficiaries against taking it any qualitative. She takes the pills herself. “The issue is how can consumers get high-quality generic drugs and how can the FDA ensure that they are of high quality?”
She is particularly interested in the foreign manufacturing of generic drugs that are released over time, such as those for ADHD. “Replicating the time-release formula can be very difficult,” Eban says.
The problem of transparency with generic drugs
She's angry because it's so hard to know where generic drugs are made.
“You can walk into a Whole Foods and know where your apples come from and how many miles they've driven, but you can't know where your generic medications are made,” Eban says.
The package generally states the name and headquarters of the generic drug manufacturer and possible side effects, but not where the active ingredients and final product are manufactured. “This information is not available to consumers,” Eban says. “It's impossible.”
Well, almost.
Michael Sargent, senior policy director at the Accessible Medicines Association (a generic drug trade group), notes that packages contain a National Drug Code, or NDC, number. It can tell you the manufacturer and packager if you look up the number on the page FDA website.
But “I think this is not a number that most patients will immediately look at and say, 'Okay, I'm going to query this NDC number and I'll find out,'” Sargent acknowledges.
One encouraging piece of news, Eban says, is that pharmaceutical companies are increasingly manufacturing generic drugs in the United States, where FDA oversight is more stringent.
How to conduct your general research
To learn about generic medications and their potential side effects, Sargent and Eban recommend talking to a pharmacist. Eban suggests not overlooking community pharmacies.
For practical research, there is the site DailyMed.gov that Jakeith used, which contains information on more than 148,000 drug package inserts, and the directory that Eban created for her own site, “A guide to investigating your drugThe Drugs@FDA area of the FDA website lets you see if there is any generic version of your brand-name drug.
“Eban is a fan of using the US Food and Drug Administration's website.”Orange book“, which lets you search for generic drugs by drug name, active ingredients, or number and then see if the agency has issued any warning letters about it.
She also recommends looking for a “certified generic” product, which means it's licensed by the branded company and is likely made with the same formula and ingredients.
What's going on with the cost of generic drugs
Generic drug prices can also vary widely, creating a squeeze on Medicare beneficiaries.
although General average price A prescription covered by Medicare Part D plans is $17 and has declined since 2009, according to the Congressional Budget Office, and 12% of Medicare beneficiaries Filling at least one generic prescription for more than $20 In 2022.
Part D insurers are increasingly moving generic drugs from Medicare Tier 1 status (for less expensive drugs) to Tier 3 (a mix of expensive generic drugs and less expensive brand-name drugs).
“In 2011, 73% of generic drugs covered in Medicare Part D were placed in Tier 1, where average cost-sharing (by beneficiaries) amounts to zero,” Sargent says. “In 2021, this has declined.” The percentage is 15%.
the Average outpatient cost For Level 3 drugs it's $42, according to health policy research firm KFF.
Many of the more expensive generic drugs are not offered by direct-to-consumer startups like Mark Cuban's Cost Plus Drugs or Amazon, according to the 2024 report. Study in the Journal of General Internal Medicine.
What's more, some generic drugs are not covered by some Part D plans, which increases the cost for people who need them.
The Biden administration is working on Demo program This would create a Medicare program that caps cost-sharing at $2 a month for thirty-day supplies of 150 essential medications (those that treat chronic conditions such as high blood pressure) without prior authorization.
Tip for shopping for a Part D plan
When Medicare open enrollment begins for 2025 in October, experts advise using… Plan finder A tool on the Medicare website to compare policies for the plans you're considering.
You'll need to find out if the plan covers your generic drugs and how much you'll pay for them.
Keep in mind that in 2025, there will be a $2,000 cap on prescriptions covered by the plan. This may help keep a lid on the costs of brand-name and generic drugs, Sargent says, because once you exceed the $2,000 threshold, your Plan D insurer will need to pay the excess amount.