Generic drugs save 43 million Medicare beneficiaries billions of dollars annually compared to the cost of their brand-name counterparts and typically sell for about 80% less. But if you think all generics are the same when it comes to side effects, manufacturing quality, price, and Part D prescription drug coverage, you’re wrong.
That’s why it’s important to do your research before purchasing a generic drug and enrolling in a Medicare drug plan. Unfortunately, this is not easy.
Fearing the generic drug problem her father faced
Just ask Susan Jackitt, a retired teacher from 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 drug. But she was nervous. Her late father contracted severe bronchitis when he replaced the same medication with a generic one.
“My doctor said I would most likely have the same problem,” Jaquith said. – And he really was right.
After she started taking the generic, “I woke up with a deep cough in my chest,” Jacquit recalls. So she decided to look for another generic that didn’t have the same side effects.
Her research at the National Library of Medicine DailyMed.gov the site showed that some generic versions of the drug contain inactive ingredients and some do not.
Eventually finding an alternative without the potentially problematic ingredients and a pharmacy that carried the generic, she ordered it. Since then, Jacquit has been taking the pills – without bronchitis – and saving a lot of money.
“I pay about $200 a year for a generic blood pressure test,” Jacquit said.
How similar generics may differ
Her experience raises the question: How can two generic versions of the same brand-name drug differ? After all, the Food and Drug Administration (FDA) states that generic drugs are “designed to be the same as brand-name drugs already on the market in dosage form, safety, dosage, route of administration, quality, operational characteristics and purpose.”
But generics may differ for two important reasons.
One of them is what Jacquit experienced: Some of them contain inactive ingredients that are generally not a problem for people taking them, but can be dangerous for people with allergies or sensitivities.
Another difference is where and how the generic drug was manufactured, which was the subject of a 2019 exposé by Catherine Eban about the generic drug industry. Bottle of lies.
ABOUT a third of generics and almost half of the active ingredients in generics immigrants from India and China. Eban found that the FDA review process can be problematic.
Concerns about FDA inspections
“In the US, the FDA shows up unannounced and works as long as necessary,” says Eban. Luck. “Overseas, the FDA is invited to conduct inspections, giving months of advance notice to companies that come in, create a Potemkin village of compliance, clean up fraudulent data and destroy incriminating documents. The whole system of foreign inspections is completely broken.”
Fortune contacted the FDA about the overseas inspections. The spokesperson said: “The FDA uses risk-based approaches to identify foreign and domestic targets for inspection and conducts both announced and unannounced inspections. For announced inspections, overseas sites are typically given 8-12 weeks’ notice. When necessary, FDA conducts overseas inspections with little or no notice to the facility, and we will continue to do so as needed consistent with our risk-based approach to inspections. We also conduct inspections with as little as 24 hours notice to the site.”
Eban does not warn Medicare recipients against taking any general. She takes the pills herself. “The question is, how can consumers obtain high-quality generic drugs and how can the FDA ensure that they are of high quality?”
She is particularly concerned about foreign production of generic, slow-acting drugs such as ADHD drugs. “A time-release formula can be very difficult to replicate,” says Eban.
The Generic Transparency Problem
She’s angry that it’s so hard to find out where generics are made.
“You can go to Whole Foods and find out where your apple came from and how many miles it has flown, but you won’t be able to find out where your generic drugs were made,” Eban says.
The packaging usually lists the name of the generic drug manufacturer, its headquarters and possible side effects, but does not indicate where the active ingredients and the finished product are manufactured. “This information is not available to consumers,” Eban says. “This is impossible.”
Almost.
Michael Sargent, senior director of policy for the Association for Affordable Medicines, a generic drug trade group, notes that packages carry a National Drug Code (NDC) number. He can tell you the manufacturer and packer if you look at the number on the package. FDA website.
But Sargent admits, “I think it’s not a number that most patients would immediately look at and say, ‘Okay, I’m going to request this NDC number and find out.’
One piece of encouraging news, Eban says, is that drug companies are increasingly producing generic drugs in the U.S., where FDA oversight is stricter.
How to Conduct Generic Research
To learn about generic drugs and their potential side effects, Sargent and Eban recommend talking to your pharmacist. Eban suggests not to overlook community pharmacies.
For practical research, there’s DailyMed.gov, a site Jakit used, which has information on more than 148,000 drug package inserts, as well as a guide Eban created for her own site:A Guide to Researching Your Own Drugs” The Drugs@FDA section of the FDA website allows you to find out if there is any generic version of your brand-name drug.
Eban is a fan of using the FDA site”Orange book“, which allows you to search for generic drugs by drug name, active ingredients or number, and then check to see if the agency has issued any warning letters about it.
She also recommends looking for an “authorized generic,” which means it’s authorized by the brand-name company and will likely be made with the same formula and ingredients.
What happens to the cost of generics?
Generic drug prices can also vary widely, leaving Medicare beneficiaries in a quandary.
Although average price of generics A prescription covered by Medicare Part D plans costs $17 and has decreased since 2009, according to the Congressional Budget Office, for 12% of Medicare beneficiaries. filled at least one prescription for a generic drug over $20. in 2022.
Part D insurers are increasingly moving generics from Medicare Tier 1 status (for the lowest-cost drugs) to Tier 3 (a combination of expensive generics and the lowest-cost brand-name drugs).
“In 2011, 73% of generic drugs covered by Medicare Part D were classified as Tier 1, where cost sharing [by beneficiaries] averages to zero. In 2021, that figure dropped to 15%,” says Sargent.
average cost of outpatient treatment according to the research company KFF, the cost of tier 3 drugs is $42.
Based on the 2024 forecast, many of the most expensive generic drugs aren’t offered by disruptive direct-to-consumer startups like Mark Cuban’s Cost Plus Drugs or Amazon. study in the Journal of General Internal Medicine.
Moreover, some generic drugs are not covered by certain Part D plans, increasing the cost for people who need them.
The Biden administration is working on pilot program it would create a Medicare program capping cost-sharing at $2 per month for a 30-day supply of 150 essential generic drugs (for chronic conditions such as hypertension) without prior authorization.
Tips for Buying a Part D Plan
Experts advise that when Medicare open enrollment for 2025 begins in October, use Search for a plan tool on the Medicare website to compare the generic drug policies of the plans you’re considering.
You’ll want to know if the plan covers your generics and how much you’ll pay for them.
Keep in mind that in 2025, there will be a $2,000 limit on covered prescriptions. This can help contain costs for brand-name and generic drugs because once you go over the $2,000 threshold, your Plan D insurer will have to pay the excess, Sargent says.