And rarely get caught or punished.

The whole system is corrupt and morally reprehensible.

No wonder our nation is suffering from the decadence and decay.

Yahweh is PISSED OFF and will allow the modern equivalent of another Sodom and Gommorah.

Just you wait…….

FDA Accountability?

Real oversight by Dingell?

Internal investigations?

Hah!

It’s not going to happen until major changes at the top of the FDA occur, which we can hope will be soon.

From The FDA Overview

FDA’s mission is:
- to promote and protect the public health by helping safe and effective products reach the
market in a timely way,
- To monitor products for continued safety after they are in use, and
- To help the public get the accurate, science-based information needed to improve health.

The FDA is responsible for protecting the public health by assuring the safety, efficacy,
and security of human and veterinary drugs, biological products, medical devices, our
nation’s food supply, cosmetics, and products that emit radiation. The FDA is also
responsible for advancing the public health by helping to speed innovations that make
medicines and foods more effective, safer, and more affordable; and helping the public get
the accurate, science-based information they need to use medicines and foods to improve
their health.

A new government audit has found that the Food and Drug Administration may have
decided to deny permission for the so-called “morning-after” pill to be sold without a
prescription well before the scientific review was complete.

The Government Accountability Office launched its year-long investigation after
lawmakers questioned whether politics, rather than science, dictated the FDA’s May 2004
rejection of the application by Barr Laboratories to sell “Plan B” over-the-counter. Plan B
is emergency contraception. Consisting of two high doses of regular birth control pills, the
drug can prevent pregnancy if taken soon after unprotected intercourse.

The GAO’s findings, released Monday, confirmed many lawmakers’ charges. “They
overruled the advice of the scientific panels and the medical staff,” said Rep. Carolyn
Maloney (D-NY), one of nearly 50 House members and senators who requested the study.
“In fact, the report demonstrates that this decision was made before the scientific review
of Plan B was even finished,” she said.

But the GAO did not determine exactly when the decision was made. Two mid-level
scientists told the GAO that superiors told them in late December 2003 or early January
2004 that the decision to deny the application had already been made. They said the
decision had come directly from the office of the FDA commissioner. The scientific
reviews were not completed until April 2004.

In an unusually angry rebuttal to the GAO, the FDA officials in question said the decision
to reject Plan B wasn’t made until months after the scientific review was complete. A
spokesman for then-FDA Commissioner Mark McClellan said the commissioner neither
made the decision, nor offered recommendations about Plan B. McClellan left the FDA in
March of 2004. He now heads the Medicare and Medicaid programs.

The GAO also found other “unusual” processes involved with the Plan B application.

For example, over the past 10 years, FDA advisory committees recommended that 23
prescription drugs be switched to over-the-counter status. Plan B’s application was the
only one to be rejected by the agency.

Plan B was also the only medication whose “not approvable” letter to the manufacturer
was signed by a high FDA official — in this case Steven Galson, acting director of the
Center for Drug Evaluation and Research — rather than by the scientists who conducted
the reviews.

The original draft of the GAO report said the reviewers declined to sign the letter. But the
FDA said officials knew the reviewers disagreed with the decision, so they were never
asked.

The GAO didn’t examine whether anyone higher in the Bush administration participated in
the decision about Plan B. But Rep. Maloney says she wouldn’t be surprised, particularly
given the pressure on the White House from conservative lawmakers and groups who
claimed that easier access to the drug might encourage young teenagers to become
sexually active.

“This is a White House that won’t even say if the president supports birth control in
general,” she told NPR. “We’ve asked (Bush) and his representatives several times
whether he supports birth control and they haven’t answered.”

Meanwhile, a revised application for Plan B is still pending at the FDA. It would allow the
pills to be sold over-the-counter to women and older teens, but only with a doctor’s order
for those younger than 16.

Still, Sen. Patty Murray (D-WA) says the problems at the FDA uncovered by the GAO go
beyond the availability of birth control.

“It is the one agency in the government that all of us rely on, on a daily basis,” Murray
said. “When we go to the store to buy a drug we need to know that it’s safe and effective
to use. If that credibility is not there, it undermines the gold standard that the FDA has not
just in this country, but in the entire world.”

FDA officials declined to be interviewed about the report, but the agency did release a
sharply worded written statement.

“We question the integrity of the investigative process that results in such partial
conclusions,” said the statement from Julie Zawisza, acting assistant commissioner for
public affairs. “The report mischaracterizes facts and does not appear to take into
consideration the input provided by the FDA. We stand by the original decision to issue a
Not Approvable letter to Barr Labs for OTC Plan B.”

GAO audit supports FDA action on Chilean gapes. (General Accounting Office)
Article from: FDA Consumer Article date: January 1, 1991 More results for: GAO FDA
Audit | Copyright informationCOPYRIGHT 1991 U.S. Government Printing Office. This
material is published under license from the publisher through the Gale Group, Farmington
Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide
copyright information)

GAO Audit Supports FDA Action on Chilean Grapes

An audit by the General Accounting Office found that FDA did not act improperly when it
suspended importation of Chilean grapes after cyanide was found in two graped imported
from that country.

FDA suspended importation of the fruit March 13, 1989, until fruit importers and FDA
could organize an inspection program. On March 17, when the program was in place, the
agency began lifting the import suspension.

The fruit importers and the Chilean Exporters Association threatened legal action,
charging that FDA’s action cost the Chilean economy $333 million and that FDA has
mishandled
What GAO Found
United States Government Accountability Office
Why GAO Did This Study
Highlights
Accountability IntegrityReliability
April 22, 2008
DRUG SAFETY
Preliminary Findings Suggest Recent FDA Initiatives Have Potential, but Do Not Fully
Address Weaknesses in Its Foreign Drug Inspection Program
Highlights of GAO-08-701T, a testimony before the Subcommittee on Oversight and
Investigations, Committee on Energy and Commerce, House of Representatives
The Food and Drug Administration (FDA) is responsible for overseeing the safety and
effectiveness of human drugs that are marketed in the United States, whether they are
manufactured in foreign or domestic establishments. FDA inspects foreign establishments
to ensure that they meet the same standards required of domestic establishments. Ongoing
concerns regarding FDA’s foreign drug inspection program recently were heightened
when FDA learned that contaminated doses of a common blood thinner had been
manufactured at a Chinese establishment that the agency had never inspected. FDA has
announced initiatives to improve its foreign drug inspection program.
In November 2007, GAO testified on weaknesses in FDA’s foreign drug inspection
program (GAO-08-224T). This statement presents preliminary findings on how FDA’s
initiatives address the weaknesses GAO identified. GAO interviewed FDA officials and
analyzed FDA’s initiatives. GAO examined reports and proposals prepared by the agency,
as well as its plans to improve databases it uses to manage its foreign drug

This got translated into……And then…..Hallburton……whatever……