Medicine cabinetDo you want your new prescription drugs to be made under last century's oversight? Like it or not, that's likely what you're getting -- or worse -- according to recent research from the Pew Health Group.

Increasingly, Americans' medicines are made overseas in place where the oversight isn't up to U.S. standards, according to the white paper, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs.

That's troublesome: According to the Food and Drug Administration, an estimated 40% of finished drugs and 80% of active ingredients and bulk chemicals used in U.S.-made drugs come from abroad.

Pew's research finds that increased outsourcing of manufacturing, a complex and global supply chain, and criminal actors create the potential for counterfeit or substandard medicines to reach U.S. patients. For economic reasons, the migration of drug manufacturing abroad is likely to continue. At the same time, industry and government agencies have failed to adapt to the changing environment, says Pew.

"Today's prescriptions are being produced under last century's oversight," said Allan Coukell, director of medical programs at the Pew Health Group, in a prepared statement. "Compared with a decade ago, pharmaceutical supply lines stretch around the world and out to a complex web of suppliers. Regulators and industry must modernize supervision of the manufacturing process to ensure the drugs we consume are safe. The After Heparin white paper identifies links in the supply chain that government and business should strengthen," said Coukell.

Substandard or adulterated pharmaceutical materials from abroad have entered the U.S. on multiple occasions, reports Pew. In addition, the risks of domestic counterfeiting and diversion of stolen drugs are well documented. The white paper presents several case studies -- including incidents involving heparin, a blood thinner adulterated during its manufacture in China; counterfeit vials of the anemia drug Epogen; and stolen vials of insulin -- to illustrate the threats.

Some Possible Solutions

What potential fixes does Pew suggest for this ailing drug system?

Companies must take responsibility for the entire supply chain by: improving oversight of contract manufacturers and suppliers; ensuring documentation and transparency of incoming drug ingredients; and developing rigorous testing standards. Drug makers must audit suppliers on-site prior to engagement and institute supplier quality agreements. Company management must be held accounting for implementing these systems.

Congress should establish national standards and oversight of drug wholesalers and require the private sector to track and verify the authenticity of pharmaceuticals.

Increased overseas inspections by the FDA, along with the expanded use of third-party sources of information to supplement FDA inspections.

It's tough to argue against these fixes: No one wants to second guess whether their painkiller will kill more than just the pain.

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annyperl

"Americans' medicines are made overseas in place where the oversight isn't up to U.S. standards" - really bad news. This fact made me upset. I haven't head about that before but i read some other reviews about harmful medicines and drugs here http://www.pissedconsumer.com/consumer-reviews/drugs.html You can check it out. We shouldn't trust adds.

July 19 2011 at 5:12 AM Report abuse rate up rate down Reply
Cesare Bonventre

You can save on your frivolous medical fees & save thousands of percent by simply ordering your meds offshore!

It has been legal since 1988 to legally mail order a 90 day personal supply of offshore meds!

Wise up America!

July 19 2011 at 4:23 AM Report abuse rate up rate down Reply
rrilea1

OR MAYBE NOT ENOUGH KICK BACKS TO OUR POLITICIANS!!!

July 18 2011 at 3:23 PM Report abuse +1 rate up rate down Reply
rrilea1

DRUG CO HAVE SO MANY ADDS ON TV AND ELSE WHERE THEY ARE BRAIN WASHING PEOPLE IN THINKING THEY HAVE SYMPTOMS THEY DON'T WHY DON'T WE BAN THESE JUST LIKE THE SMOKING ADDS AND LET THE DOCTORS DESIDE IF YOU NEED ANY OF THESE DRUGS. MAYBE TOO EASY?

July 18 2011 at 3:19 PM Report abuse +2 rate up rate down Reply
larry & gail

As a pharmacist I saw this coming years ago remember NAFTA ??

July 18 2011 at 2:37 PM Report abuse rate up rate down Reply
mountainez

Is this the same country that told us a few years ago that we couldn't get drugs from Canada or anywhere else because they were not safe? What a huge joke! I wonder who in the government was paid off by the BIG PHARMS to change the rules. Money talks wants again!

July 18 2011 at 10:16 AM Report abuse rate up rate down Reply
wilster008

The solution to the problem is clearly stated in the article. I don't think we are going to be able to do this while the right-wing extremists are running the show in Washington .

July 18 2011 at 7:52 AM Report abuse +2 rate up rate down Reply
defelicep

Legal prescription drugs kill between 100,000 and 200,000 people every year when properly prescribed yet the FDA goes after alternative medicine and supplements as if they were poison and yet no deaths have been reported by the Posion Control Center RE: supplements in at least 15 years. Although some have released some great beneficial drugs, drug companies have falsified their science and lied over and over again about the true affects of their product thus committing more crimes against humanity than any other organization or even terrorists. I don't trust them as far as I can throw them.

July 18 2011 at 7:42 AM Report abuse +3 rate up rate down Reply
cavekarst

What drugs? I had surgery to repair accident damage. I was taking something for pain just recently. A prescription
that people abuse. When the bandaged area skin color was clearly returning to normal I put aside my remaining pills.
It wasn't childbirth agony but this was something I can live with until end of July. I do the twice daily dressings and
saline solution rinses. If you need drugs to be good or just normal every day I'd guess you're more damaged than me.

July 18 2011 at 1:23 AM Report abuse rate up rate down Reply
bumper870

If products where made in The USA It would solve Problems.
Jobs would return to The USA.
Why not charge enough to test drugs made abroad. Jobs here plus the money
to inspect the drugs.
The foreign company want our markets, then have the work for it and pay for.
The States has the best market in the world. Overseas does not own our markets.
If American companies were not so greedy. they are already rich. they just want more. They
have ceased to be American when they sent their manufacturing jobs across the oceans.
Bring every thing Home!

July 17 2011 at 11:20 PM Report abuse +3 rate up rate down Reply