F.D.A. Is Unable to Ensure Drugs Are Safe, Panel Is Told

[Lone_Star_Dem]

Source: New York Times

The Food and Drug Administration cannot guarantee the safety of the nation’s drug supply because it inspects few foreign drug manufacturers and the inspections it does carry out abroad are less rigorous than those performed in this country, witnesses told a Congressional subcommittee yesterday.

While foreign companies manufacture as much as 80 percent of all ingredients used by American drug makers, the drug agency’s record keeping is so poor that it cannot say which of those have not been inspected, according to the testimony before the House Energy and Commerce Subcommittee on Oversight and Investigations.

“More than nine years after we issued our last report on this topic, F.D.A.’s effectiveness in managing the foreign drug inspection program continues to be hindered by weaknesses in its data systems,” Marcia Crosse, director of health care for the Government Accountability Office, said in a statement to the committee.

The agency is supposed to inspect domestic drug makers every two years, but there is no such requirement for foreign suppliers, even though foreign factories are more likely to have quality problems, witnesses said.

Read more: http://www.nytimes.com/2007/11/02/washington/02FDA.html?ex=1351656000&en=d2cbec47a5cae2bb&ei=5088&partner=rssnyt&emc=rss

[rodeodance]

1. recall Repugs had a cow ----would NOT allow imports from Canada and now we find this out!

[Bozita]

20. If the GOP were concerned with our health, they would ADVOCATE importing drugs from Canada

Canada's version of the FDA works a lot better than ours.

[UpInArms]

2. file this one under "do'h"! this mal-administration has disabled

every branch of oversight within our government and given it to the corporations for a snack.

[rodeodance]

4. NO< do not file away for heavens sake--Raise a stink about it and demand answers!

[UpInArms]

11. sorry rodeodance - I didn't mean to imply that it was going in the

circular file - just the do'h! file -

outrage is my middle name - has been now for years

:hi:

[Beerboy]

23. Yay! Yummy Chinese drugs! Now with Lead!

I can't wait for the New-and-Improved stuff w/ depleted uranium!:9

[rodeodance]

3. 'the drug agency relied on volunteers to conduct foreign inspections and that inspections were often

The accountability office, the investigative arm of Congress, also found that the drug agency relied on volunteers to conduct foreign inspections and that inspections were often determined by travel schedules and not need.

Another problem, witnesses said, is that the agency gives foreign drug makers advance notice of inspections, in contrast to the unannounced inspections in the United States. In some cases, agency inspectors have to rely on the company being inspected to provide translators.

[rodeodance]

5. AND please send to WH-----contact HERE:

[e-mail]

[soothsayer]

6. the FDA calls the drug companies its "clients." WE are supposed to be

the clients, dammit!

[deminks]

7. Dry wall and road paint

Remember the segment that 60 Minutes did on fake drugs coming from the orient. Some were made with ground up dry wall and road paint. Now they are telling us there is no way to tell.

I want my country back. I want a country back. Bush and friends have destroyed us.

[no_hypocrisy]

8. Let me get this straight:

1. The FDA can't determine whether a drug is entirely beneficial or partly dangerous for a consumer to ingest;

2. The same so-called medicine will be prescribed unknowingly by a physician who either trusts it inherently or is convinced by a friendly pharmaceutical rep that this is a miracle agent; and

3. The patient with a compromised constitution will trust the physician and ingest that drug and perhaps further comprise his/her health if not life with that drug -- and pay too much for the same drug to hurt or kill him/her.

[gratuitous]

9. Don't forget one other point

Being forced to take your shoes off before boarding a plane will make us all safe, safe, safe from a terrorist attack.

[deminks]

10. Nice summary.

Might add

4. If the patient's lucky to have prescription insurance and has a mail order service, the prescription police will call once/month to make sure said patient is taking the medication and will order the renewal on time, but can't be sure what the patient is actually taking. If said patient should (gasp) stop taking the medication, they will need to have said physician notify said mail order service to be certain said patient didn't (gasp) stop the medication on their own, whateverthehell it is made of.

[Bitwit1234]

12. BUT foreign manufacturers are our outsourced jobs.

they can be sent back into this country with inflated prices. That's so the companies that went overseas can increase their profit. The drugs from Canada have a more reasonable price. We can't have that. The poor drug companies won't make as much money.

[Bruce McAuley]

13. Most Americans don't realize how bad our drug system is compromised...

My wife is extremely sensitive to drugs and oddball ingredients.
Many of the pain killers for example are "ringers".
A certain percentage just plain don't work. I estimate about 20 to 40% are fake.
I've followed the trail back to the manufacturers, and they claim after the pills leave their control they have no more responsibility.
Nobody controls the middlemen.
Our local pharmacy buys from one of 3 suppliers in our state, and they of course buy the cheapest drugs they can.
Result?
We get fakes in the supply line.
If I were a middleman, the temptation to slide some of the real pills aside and replace them with cheap fakes would be very hard to ignore.
Not only is the cost less, but additional money can be made selling the real drugs on the black market.
If I can see it, anyone can.
Nobody claims responsibility to control the quality at the consumer point of sale.
Big hole for profit by the unscrupulous.

Bruce

[FloridaJudy]

14. Excuse me?

Big Pharma has been having a cow, and putting ads in all the media saying if Americans buy drugs from Canada, "the quality may be bad". And our own drug companies are using untested ingredients made by other countries?

Does not compute. "Danger, Will Smith".

[WilyWondr]

17. exactly

http://www.fda.gov/oc/opacom/hottopics/importdrugs/stmt042006.html

The drug distribution network for legal prescription drugs in the U.S. is a "closed" system that involves several players (e.g., manufacturers, wholesalers, pharmacies) who move drug products from the point of manufacture to the end user, and provides the American public with multiple levels of protection against receiving unsafe, ineffective, or poor quality medications. This system evolved as a result of legislative requirements that drugs be treated as potentially dangerous consumer goods that require professional oversight to protect the public health. The result has been a level of safety for drug products that is widely recognized as the world's "gold standard."

:rofl:

We have found that although "Canadian pharmacies" purport to dispense drugs that are FDA approved, generally the drugs, in fact, are not. Rather, the dispensed drugs are of unknown quality and country of origin.

Buying beef from Mexico or Fish from China is no problem though....right FDA?

[kcass1954]

15. Can't??? Or won't???

I can understand that the FDA may not be able to properly inspect overseas facilities. But they most certainly can prevent un-inspected drugs and ingredients from reaching consumers. They have the power to do this with existing regulations.

Domestic manufacturers' use of unregulated ingredients helps no one but big pharma. It's the almighty dollar controlling the manufacturers, and they in turn are controlling the FDA.

Good luck if you get sick!

[DeepModem Mom]

16. K&R

[OhioChick]

18. Nice....

No one inspects jack shit anymore, do they?

K&R
:kick:

[Trillo]

19. They sure seem to be able to disrupt pseudoephedrine hydrochloride

because it's used by a few to make Methamphetamines.

<sarcasm>

The War on Citizens is good. The War on Illegal Drugs is good. The War on Legal Drugs, whose precursors might be used to make an illegal drug, is good, even if people who use the legal product are negatively effected. Everyone must sacrifice to rid our world of this scourge.

The War on Corporate precursor drugs is bad, very, very bad. It "cannot" be done. Corporate cannot and will not sacrifice.

</sarcasm>

[Historic NY]

21. Another way for our government to kill us...........

they skip inspecting food, meat, imports, now drugs. WTF do we even have them if their not doing their job. I guess its more mindless cronies in charge.

[Beerboy]

22. Yay! I hope my drugs are made in China!

Is the FDA part of the Department of Booga-Booga ('Homeland Security') now?
This is fucking bullshit.
We The People are paying you, do your job!

[Orsino]

24. Stop spending on *'s war, start spending on security....

...and don't ever confuse the two again.

[Historic NY]

25. The Bush administration is unable to keep Americans safe.....

if our food is contaminated and our drugs can be, whats to say that the terrorists are not doing it. The Buffoon in the W.H. has left us open to other forms of attacks due to his malfeasance in administrating his duties. American and its citizens are less safe than they were before 9/11 due to incompetence.

[BlueIris]

26. Sigh. In other news, water is wet.