Audio Transcript

Those attending the meetings are:

• Steve Smith
• Karen Johnson
• Greg Edwards
• Kathy Williams
• Jason Woo (Appears for FDA Insight)

Smith: Alright, I need to bring everyone's attention to the next order of business. The FDA has taken another action to remove unapproved drugs from the marketplace. We need to know what impact this initiative might have on our business. Listen, I know of several firms that have already received warning letters, and one had their product seized. I have two questions. One, do we have any unapproved marketed drugs? And, if we do, what are we going to do about it?

Williams: Well, I have looked at our portfolio and there is one product. It's an older prescription pain medication. I mean, it's been around for years and it's been marketed without approval.

Johnson: Well, let's get it approved.

Edwards: Hold on, let's think about this for a minute. The active ingredient has already been approved by the FDA. I know of other drug products that are being marketed without approval. So, what are the advantages of even having FDA approval?

Woo: Just because your drug's active ingredients are in a product approved by the FDA for another firm doesn't mean it is OK for you to market your product---or that it is safe! Generally, for a drug to be marketed legally it must either get FDA approval, or comply with an OTC drug monograph. The FDA's drug approval process provides a review of product-specific information that is critical to ensuring the safety and efficacy of each particular finished drug product. Unapproved drug products have not received the rigorous scientific evaluation that occurs during the drug approval process. Therefore, they may not meet modern standards for evidence supporting their safety and effectiveness. Also, there is a manufacturing process along with information that demonstrates the manufacturer can reliably produce the drug to the expected level of identity, strength, quality, and purity. The advantage of FDA approval is knowing that you are providing a safe and effective product to the consumers who rely on it.

Johnson: Obtaining FDA approval is very important; we have thousands of people taking our drug. I believe we owe it to those that are taking our products, and I believe we owe it to our business.

Williams: Well, look Karen I understand your concern, but frankly, I don't think we should spend the money on getting the drug approved.

Smith: Kathy, tell us why you think that.

Williams: The drug has been on the market for years. I just don't think we should spend our resources to get the approval.

Woo: There are costs associated with going through the drug approval process. However, it is important to realize the consequences of choosing not to go through the approval process. Without formal approval by the FDA your firm could be required to take your drug off the market and thus significantly impact your business. In the last several years, FDA has taken action against about 500 unapproved drug products. Unapproved drugs raise significant safety concerns for the FDA and remain an enforcement priority for the Agency. Firms should work proactively to get FDA approval.

Johnson: It would be awful to have our drug removed from the market. Can you imagine the impact on the company? I know it's a large expense upfront, but in the end, I believe it will be worth it. It's the right thing to do.

Smith: You know, I agree with you Karen. It's important that we remain in good standing and compliant with the FDA's requests. A lot of people do use this drug, and we have got to do the right thing. You know, in the long run, it will probably end up saving us money if we seek approval. My only concern now is that process is lengthy and cumbersome. Do we have the resources?

Woo: The drug approval process does take some time, but the FDA has worked diligently to streamline the process in order to allow companies to get their approved drugs to market, while maintaining the standards necessary to protect public health. All information on the drug approval process and related forms are available on the FDA's website. There is also a WebLearn course that will guide firms through the process and provide them with important FDA resources. FDA has established this WebLearn course to help those marketing unapproved drug products to understand the application process and regulations so they may bring their products into compliance.

Williams: Karen, after hearing your points, I think you're right. You know, if we're going to provide this drug, then I think we need to do it the right way. You know, this company was built on the principal that we should always strive to be socially responsible, and THIS is the responsible thing to do. I'll go to the FDA website and start on the WebLearn course.