Disturbing Truths about FDA-Approved “Generic” Drugs

By Lee Bellinger / November 12, 2013

Generic or Name Brand Drugs
Nowhere has government interference in your life created a more nightmarish result than with pharmaceuticals. Far-off bureaucrats decide what you can buy, what you can’t buy, and to a large measure control or influence the prices you pay.
The worst part: you may not be getting the health benefits you need, or the benefits you think you are getting, from the drugs you are now taking.
Our interest is in taking care of our health as well as our wealth – and helping our readers do the same. So today we’re giving you a primer on generic drugs that – in just a few minutes – can help you understand this complex situation.
For nearly three decades, you’ve been able to request a generic version of many of your prescriptions at the pharmacy. You save significant money when you do, so it seems like a smart idea.
You get the drugs your doctor says you need without going broke. Your insurance company is happier about paying the lower price. Your doctor doesn’t seem concerned one way or another, as long as you take your medicine on schedule. The only obvious loser in the equation is the company selling the brand-name drug, and they had the chance to hold the patent for years, so they should have made their money already. Right?
If only it was that easy. Unfortunately, there’s a lot more to the generic prescription drug equation. It’s possible that you could be undermining your health when you choose generic drugs or are forced into them by your prescription plan.
Today, we’re going to tell you what you need to know to get the best deals on your prescriptions while safeguarding your health…

Here’s Why You Need to
Take a Closer Look at Generic Drugs

Generic Pill
In 1984, the government established new regulations and procedures that apply to generic pharmaceutical drugs. Under the new regulations, companies producing a biological and pharmaceutical equivalent to a therapeutic prescription already on the market did not have to submit data from clinical trials to gain approval.
This shortened the approval process and greatly reduced the generic drug manufacturer’s research and development costs. With these regulations, a company could submit the active ingredient in their generic alternative for a bioequivalence review along with a proposed label – that was all it took to begin the approval process. These requirements are minimal compared with the extensive research and testing that goes into the development of a new drug.

All Things Being Equal…
When They Really Aren’t

The generic approval process helps to ensure the basic safety of generic drugs, but it does not ensure equal results between generic drugs and the brand-name drugs they are based upon. True, the active ingredient is the same, but the other components might be different.
For example, many drugs these days work on a time-release formula. That means the drug releases into your system gradually throughout the day. The patents on time-release formulas used by pharmaceutical companies never run out. So when a generic drug manufacturer makes a similar drug, they have to come up with their own time-release formula.
And they don’t have to do clinical trials to see how it works. They only have to show that the active ingredient is bioequivalent to a mainstream drug to get a green light from the FDA… even if the time release is different and makes the effects of the drug different.
In one case, a woman taking the antidepressant drug Wellbutrin ended up on a generic version without realizing it. While on actual Wellbutrin, she felt great, but when her prescription was changed to a generic, she gained weight, suffered from fatigue, and struggled with insomnia. Because her pharmacist hadn’t informed her about the switch, she didn’t realize it was the generic drug causing the problems. It was eight months before she discovered the real problem, and during that time her doctors had prescribed a host of other prescriptions to help her deal with the side effects caused by the generic drug.

Nowhere to Turn Except the
FDA’s Overloaded Complaint “IN-BOX”

In addition to the potential for very real differences in the effects of generic drugs, you need to know that your options if you are harmed by a generic drug are pretty limited. In a recent court ruling, the U.S. Supreme Court determined that people suffering unexpected side effects from generic drugs cannot sue the drug makers. You can still sue brand-name manufacturers, but generic drug companies are shielded from class-action lawsuits.
FDA
Generic drugs may also contain different inactive ingredients than the brand-name equivalents. Those inactive ingredients may become the cause of unexpected side effects.
In addition, nearly 80 percent of the active ingredients produced for generic drugs are made in overseas factories. Often, the level of oversight and the number of inspections for these factories is far below what is expected for factories located in the U.S. That simply means that the ingredients in your generic drugs may not be as safe as you believe. U.S. lawmakers and drug manufacturers have a plan in place for improving overseas inspections, but it has yet to be implemented.
So, what should you do?

YES, There is a Smart Solution
to the Generic Drug Question

We know drugs are expensive. So, we know the appeal of generics, and we’re not going to suggest that you swear off them. But, you can take steps that will help safeguard your health.
    • First, talk to your doctor. Ask him about the brand-name prescription and what generic options are available. It’s especially important that you find out if the drug he’s prescribing has a time-release formula, because that is what can really change the effects if you end up on a generic. You should also ask if he’s had any patients with a similar level of health to your own who’ve experienced difficulty with any of the options.
Talk to Your Doctor
  • Second, ask questions at the pharmacy. In many states, your pharmacist can switch your prescription to a generic – without telling you. In a case where you have multiple generic options for a single drug, you may be getting a completely different formula from one refill to the next. Ask your pharmacist what specific drug he’s given you. Record the information and keep track of anything that’s different for you during the month. Do you have more energy or less? Are you gaining weight? Has it impacted your appetite, your sleep schedule, or your mood? Keep track of these kinds of things and watch for patterns. Eventually, you can determine which option (generic or brand name) works best for you, and then you can insist on it.
  • Third, if you’ve had any recent changes to your health and you’re on prescription medications, check into the possibility that you’ve been switched from a brand name to a generic – or from one generic to another. That might be what’s causing the changes. Alternatively, if you’re on a prescription that’s working really well for you, ask your doctor to add a “no substitutions” order to your prescription. This should protect you from unexpected changes.
  • Fourth and finally, watch for recall notices. The FDA posts these on its website: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm. The sad truth is that some very real problems exist with generic drug quality control. Sometimes generic drugs get mislabeled, and sometimes the dosages aren’t measured properly, to name just a couple of examples. So stay informed. It could save your life.

Don’t Count on the System Totally!
Be an Active Participant in Your Health

There was a time when you could rely on your doctor and pharmacist to look after you. You didn’t have to give much in the way of a second thought when it came to following a doctor’s orders or taking the prescription you picked up at the pharmacy. But, that time has passed.
These days, if you don’t practice more self-reliance when it comes to your health, you could find yourself in real trouble. So, pay attention, take an active role in your medical care, and look for ways that you can reduce your dependence on our current system.
In the meantime, we’ll keep letting you know what to watch out for and what you can do to protect your health and the health of those you love.