Animal Health Solutions

More at: northamerica.covetrus.com/publications Animal Health Solutions | 21 MYTH 3 Private brand generic drug manufacturing facilities and processes do not have to meet the same standards as those for brand-name drugs. Both brand-name and private brand generic drugs must be manufactured to the same high quality standards of the FDA. They all must be manufactured in FDA-inspected facilities, must meet current "Good Manufacturing Practices" guidelines and must be shown to be safe and effective. MYTH 4 Private brand generic drug manufacturers do not monitor their drugs for adverse events and quality complaints post-approval like brand-name drug manufacturers do. The FDA's post-approval requirements for brand-name drugs and private brand generic drugs are identical: • Pharmacovigilance (adverse event and quality complaint) monitoring/reporting • Reporting of manufacturing changes • Ongoing stability testing • Submission to FDA of advertising and promotional materials MYTH 5 Selling private brand generic drugs over brand-name drugs will decrease your clinic revenue. Historically, many veterinarians have taken a general approach to drug pricing: one markup fits all. So, if you simply double your cost to create the selling price to your clients, then yes, you will decrease your pharmacy profit by selling private brand generics over brand-name drugs. However, if you focus on maintaining your desired gross profit margin and adjust your pricing strategy accordingly, you will increase your pharmacy profit and save your clients money. It will benefit you to base pricing on the gross margin or profit dollars you target for each drug in your pharmacy and set your client pricing based on your target margins. The desired gross margin should drive your markup, not the other way around. The markup is the ratio between the cost of a good or service and its selling price (client charge). Markup is expressed as a percentage over the cost. Sell price of drug x to client - DVMʼs cost of drug x DVMʼs cost of drug x Blood-level bioequivalence studies compare a test product (private brand generic) with a reference product (brand-name drug) using parameters measuring and encompassing absorption, distribution, and depletion of the drug concentration over time. To determine bioequivalence between the products, the manufacturer of the private brand generic drug completes blood-level studies comparing its formulation with the brand-name formulation and reports to what extent the active ingredient concentrates in the blood and for how long. The average or mean results for the two products must not be significantly different. Designing, conducting, and analyzing a bioequivalence study can take up to three years to complete. The requirement for the bioequivalence study may be waived for certain private brand generic products, including parenteral or oral solutions, if certain criteria are met. MYTH 2 A private brand generic drug can have up to 20% less active pharmaceutical ingredient. To conduct the bioequivalence study, the same dosage is used for both the brand-name and private brand formulations. The FDA-CVM considers two products bioequivalent if the mean peak concentration and area under the curve are not significantly different when applying a 90 percent confidence interval approach. The acceptable limits are that the private brand product mean must be within 80 percent to 120 percent (untransformed data) or 80 percent to 125 percent (log-transformed data) of the mean of the reference product. This allows for individual animal variation in the live animal study. This does not mean that the private brand generic drug is allowed to have 20 percent less active ingredient than the brand-name drug. Private brand generic drugs must be formulated to contain the same amount of active ingredient as brand-name products. Both brand-name and private brand generic drugs must be manufactured to the same high quality standards of the FDA.

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