FDA in the News Again

The Government Accounting Office (GAO) released a report earlier this week which says, "FDA lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues."

The report was released by Senate Finance Chairman Charles Grassley, who requested the report in late 2004 on the heels of the withdrawal of Vioxx by Merck and Co, Inc. Grassley said, "This report provides solid evidence that everything is not all right at the FDA and calls for long overdue reform. The FDA’s problems are systemic and cultural, not isolated or easily fixed."

Stay tuned, as Congress decides how to go about "fixing" the FDA.

What does this mean for us as we go about our daily business of manufacturing products regulated by FDA?

Be sure our people are well trained in cGMPs as well as our internal policies and procedures. It’s likely that those employed by FDA will "hunker down and play it safe" (being very cautious and conservative) while they are under the microscope.

GMP Training Systems, Inc.
Experience You Can Trust
www.GMPTrainingSystems.com

Need to freshen up your GMP training? Our expert faculty can help you make GMP a Lifestyle in your organization. Go to http://www.gmptrainingsystems.com/asp/inplant_training.asp to learn more about how our in-plant training can help you.

A Bad Week for our Industry

Our industry was in the news last week. Unfortunately, the news was bad news. Even though only two companies were involved, this news shines a negative light on the entire industry. The best way to stay out of this light is to pursue quality and stay compliant with FDA's regulations.

First news story

A New Jersey man was awarded $13.5-million from Vioxx maker Merck & Co. after a jury found the company withheld data about the drug's risks from federal regulators. In the trial, the jury was asked the following questions and gave the following answers:

Q: Has the plaintiff proved by clear and convincing evidence that Merck knowingly withheld or misrepresented information required to be submitted to the FDA under the FDA regulations which information was material and relevant to the harm in question?
A: Yes.

Q: Has the plaintiff proven by clear and convincing evidence that Merck’s actions show a wanton and willful disregard of another’s rights so as to justify an award of punitive damages?
A: Yes.

Merck & Co., which is already facing 9,650 lawsuits over its former blockbuster pain reliever Vioxx, could have another fight on its hands, over its promotion of osteoporosis drug Fosamax. According to a federal lawsuit filed April 10 in Fort Myers, Fla., Fosamax can cause osteonecrosis of the jaw, or a rotting of the jaw bone. The suit, which seeks class-action status, alleges that Merck has concealed Fosamax's potentially dangerous side effects.

This has to be a major distraction for Merck's management and certainly will impact morale throughout the organization.

Second news story

Bausch & Lomb Inc. said it doesn't plan to recall a contact lens cleaner linked to eye infections and defended the product's safety as retailers, including Walgreens, Wal-Mart, CVS and Jewel-Osco, pulled the solution from their shelves.

Chief Executive Officer Ron Zarrella said on April 12 that ReNu with MoistureLoc kills the fungus that causes the cornea infection and he might start a marketing campaign to restore confidence in the product. Bausch & Lomb's stock fell for a 15th straight day.

On a conference call with analysts, Zarrella declared ReNu with MoistureLoc is "as safe and effective as anything on the market." Bausch & Lomb stopped shipping the product Monday after the U.S. Centers for Disease Control and Prevention said it was investigating 109 reports of fungal keratitis. "There's no indication there is a formula problem here," Zarrella said.

Perhaps Zarrella should study the case when Johnson and Johnson recalled 31 million bottles of Tylenol after seven people died of poisoning by cyanide introduced into bottles on store shelves. This incident and J & J’s reaction has become the textbook case for effective product crisis management.

The first story reminds us of how critical our work is in the pharmaceutical and medical device industries. Our customers are called patients.

The second story reminds us of the importance of following current Good Manufacturing Practice.

Training Tip

Use news stories and events like these to reinforce the need to follow GMP and remind people that our customers are called patients and that the consequences when something goes wrong can be severe.

GMP Training Systems, Inc.
Experience You Can Trust
www.GMPTrainingSystems.com

We have three audio seminars scheduled for next week. Go to www.gmptrainingsystems.com/asp/lcgc_archives.asp to see our listings.

FDA's New Proposed Rule for Medical Gases

The Food and Drug Administration (FDA) issued a proposed rule on April 10 designed to make the contents of medical gas containers more readily identifiable, in order to prevent deaths and injuries from inadvertent use of incorrect medical gas or from use of contaminated medical gas. Between 1996 and 2006, the agency received reports of medical gas mix-ups that resulted in at least 8 deaths and 18 serious injuries.

All medical gases are prescription drugs regulated by FDA and, accordingly, must be manufactured and distributed in compliance with applicable laws and regulations, including existing FDA Current Good Manufacturing Practice (CGMP) regulations. In the Federal Register of May 6, 2003 (68 FR 24005), FDA announced the availability of a draft guidance for industry entitled "Current Good Manufacturing Practice for Medical Gases" (draft guidance). The draft guidance provides recommendations for CGMP compliance in the manufacture and distribution of medical gases which are intended to avoid medical gas mix-ups and contamination.

Go to www.GMPTrainingSystems.com/asp/resources.asp where you can download and read:

• FDA's Press Release issued April 10, 2006
• FDA's Questions and Answers on this new proposal
• cGMP for Medical Gases (draft guidance)

GMP Training Systems, Inc.
Experience You Can Trust
www.GMPTrainingSystems.com

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