You just received a call from Gwen Hodges, PhD and Bill Hambridge, MD, the same duo you were introduced to in the mid-term exam. However, this time, they have decided to consult with you before they begin doing anything. Good for them!

Gwen and Bill have legally purchased all rights and title to NoDrip (driemup acetate).

• The FDA will approve NoDrip as an innovator drug for being able to treat asthma, even though driemup acetate is a generic compound and currently used in allergies.
• NoDrip is a solid oral pill. Dosing will be 1 pill per day for 6 months.
• It will be distributed through regular wholesalers - neither specialty distributors nor specialty pharmacies will be needed.
• FDA drug safety monitoring regulations are found in 21 CFR 314.

Assignment

You are a pharmaceutical business consultant with extensive knowledge about all facets of the business and law (even though you are not a lawyer).

Gwen and Bill hire you to tell them what they need to do to get the drug to market in the US and what they should do, and not do when marketing NoDrip. They also want you to comment on how to price NoDrip and contract it with the various middlemen between their company and patients.

Gwen and Bill have many questions for you, listed below. Please respond to each of their questions, ensuring that you address all elements of multi-part questions. Cite the law and/or regulation that supports your answer, if applicable. Your answers should be drafted in a separate document, including the headings and question numbers. Once finalized, be sure to save your document and then upload it to the course site.

FDA and Clinical Considerations

1. Will we need to get FDA approval to market NoDrip in asthma? Why?
2. Will we have to study NoDrip clinically (in humans)? Generally, what would that clinical development program look like - what does the FDA require?
3. What kind of efficacy studies does the FDA require in Phase III?
4. How do we ensure clinical trials are kept HIPAA compliant?
5. Do we need to compile anything and give it to the FDA in order get FDA approval? If yes, what are the main elements of the compilation?

Marketing and Advertising

1. When we file the NDA, can we market the drug that day?
2. When the drug is marketed, do we have to worry about monitoring for safety signals? If yes, what do we need to do? What might happen if we don't?
3. What are 4 things we should do/not do in the advertising materials? For example, balance safety and efficacy messaging?
4. We think the drug is going to be promising in warts. What is your advice about our approach to marketing for use in warts?
5. We want nurses to market NoDrip alongside our sale representatives. How do we make that happen compliantly?
6. What is the most compliant way to pay the physicians who are going to do clinical trials on NoDrip? Why that way?
7. We want our sales representatives to review patient medical files to help ensure that patient has insurance coverage for NoDrip. Do you have any advice about this proposed activity?

Sales Contracting and Pricing

1. We would like to pay physicians who prescribe NoDrip $100 per prescription. What is your advice about this proposed plan?
2. With whom should we contract to get the drug from our manufacturing plant to pharmacies, and to get NoDrip insurance coverage?
3. If we must contract with wholesalers, PBMs, payors, do you have any advice on how to contract compliantly?
4. NoDrip will be used by Medicaid patients. Will we have to pay Medicaid rebates? What would be the right amount of rebate?
5. We would like to have some exclusive contracts with and pay big rebates to PBMs to block out our competition to ensure NoDrip is the only asthma drug on formularies. What advice do you have for us?
6. The state and federal governments sure are putting a lot of pressure on companies about drug prices. We need to make money to pay-off our investors and to make a profit to sustain the company and fund R&D. What advice do you have for us on how to price NoDrip in the US?