Pharmaceutical Companies Contradicting Official Safety Warnings

According to The Washington Post The Food and Drug Administration is proposing to allow pharmaceutical companies to contradict official safety warnings in sales presentations to customers.

Though an FDA warning can scare off buyers, the new proposal would allow drugmakers to present customers with information that undermines official warnings as long as it comes from a peer-reviewed journal article.

The proposal is supported by the manufacturers, who argue the policy would allow them to give doctors and hospitals the benefits of the latest research.

But the proposal is drawing criticism from public-health advocates, who argue that because individual studies can differ widely in their results, a drug company could easily mislead customers - and possibly endanger patients - by presenting only a selection of new research.

The proposal "seriously undermines FDA authority," Sidney Wolfe, founder of Public Citizen's Health Research Group, wrote the agency. "Its main supporters are drug companies and their associations, all of which would benefit from being allowed and encouraged to sell more drugs by making them seem safer than FDA has judged them to be."

Under the proposal, the FDA would not "object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling." Studies must be "well-designed" and "at least as informative as the data sources" the FDA used in generating the official warning.

For example, a drugmaker could present evidence that the severity or frequency of a side effect is less than that suggested by the FDA-approved label. Or it could question whether the drug causes the side effect at all.

Exactly what drugmakers can tell customers has been the subject of regulation and sometimes - when the side effect has led to heart attacks, cancer, or suicide - billion-dollar penalties. But the industry has pushed back in recent years, arguing that under First Amendment, the government cannot curtail their right to disseminate information.

The proposal seems bound to increase drug sales because it is explicitly geared toward undermining the FDA warnings, rather than enhancing them, critics said. The proposal allows the dissemination of information that "rebuts or mitigates" the risk identified by the FDA, or information that "refines" the risk as long as it "does not indicate greater seriousness of the risk."

In a letter to the FDA, the pharmaceutical industry's chief lobbying group, PhRMA, said that while the agency has an "important role in evaluating the safety and efficacy of new medicines . . . we also must recognize the critical need for health-care professionals to receive the most current, accurate and comprehensive scientific information."

"The Constitution's protection of an open and robust exchange of ideas . . . limits FDA's ability to regulate scientific communication," according to the letter signed by PhRMA vice president Jeffrey K. Francer. "PhRMA respectfully submits that FDA should give additional consideration to these First Amendment limitations in issuing final guidance."

Unsafe and Contaminated Medications Released To American's

The Brooklyn (NY) Daily Eagle reported that “the federal

government” has “unsealed a 37-count indictment

charging Med Prep Consulting Inc. with wire fraud and

violations of the Federal Food, Drug and Cosmetic Act

(FDCA).” The company, “together with its owner and

president, Gerald Tighe, and pharmacist-in-charge,

Stephen Kalinoski, allegedly introduced adulterated and

misbranded drugs into the commerce stream and

misbranded drugs with the intent to defraud and mislead

the US Food and Drug Administration (FDA) and Med

Prep’s customers, who consisted of hospitals and other

healthcare providers.” The Daily Eagle added,

“According to the indictment, Med Prep processed

numerous drugs...in purportedly sterile conditions. In an

effort to gain market share, Med Prep repeatedly

misrepresented to its healthcare provider customers that

 it adhered to, and in some areas exceeded, industry

standards and laws applicable to sterile drug

preparation.” FDA Commissioner Hamburg said, “The

production of unsafe and contaminated drug products

poses a serious threat to the health of the American

public and cannot be tolerated.”

Ranbaxy Pays $2.3 Million To Settle Unsafe Medication Lawsuit!



The Oregon Department of Justice has also settled a case with Ranbaxy Laboratories Ltd. and two affiliated American companies. Pursuant to the settlement, $2.3 million will be paid to the state. It was discovered that Ranbaxy sold generic prescription drugs in Oregon that were not safe for consumers. A whistleblower case in federal court revealed that the company had been shipping substandard generic drugs to the United States, some of which were distributed in Oregon. While that case settled for $500 million, the money allocated to Oregon’s Medicaid program did not cover the full cost of drugs purchased from Ranbaxy.


The Ranbaxy-manufactured drugs in question include amoxicillin, a widely prescribed antibiotic; clavulanate potassium, used in combination with antibiotics to treat drug-resistant bacteria; and sotret, an acne medication. Medications manufactured by Ranbaxy have been subject to safety concerns outside of Oregon.