Generic Drugs - What You Want to Know About Generic Drugs

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What You Want to Know About Generic Drugs:

What You Want to Know About Generic Drugs Generic Drugs: Safe. Effective. FDA-Approved.

What do you want to know about ALL the medicines you use…. brand-name and generic?:

What do you want to know about ALL the medicines you use…. brand-name and generic? safe and effective affordable and available use with confidence

Myths about Generic Drugs:

Myths about Generic Drugs Generics…are not as safe Generics…are not as potent Generics…take longer to act in the body Generics…are made in sub-standard facilities

What You Want to Know About Generic Drugs:

What You Want to Know About Generic Drugs I. How FDA assures that generics: are Safe. Effective. FDA-approved. are an affordable alternative can be used with confidence

What You Want to Know About Generic Drugs:

What You Want to Know About Generic Drugs How FDA and the administration are working to make more generic medicines available to the American public

What You Want to Know About Generic Drugs:

What You Want to Know About Generic Drugs Brand-name drug Generic drug supplied by one drug company sold under drug company’s trademarked name may be supplied by more than one company may be sold under active ingredient(s) name(s)

What is a generic drug?:

What is a generic drug? A copy of a brand-name drug, which must have the: same quality same safety same strength

What You Want to Know About Generic Drugs:

What You Want to Know About Generic Drugs Both brand name and generics drugs: are approved by the FDA must meet the same FDA standards for quality

Generic Competition:

Generic Competition It is essential to have brand-name and generic drugs available.

Generic Competition:

Generic Competition helps keep drug costs down encourages research helps keep insurance premiums down saves consumers $8 to $10 billion yearly

Patent Protection:

Patent Protection A patent: protects the investment of the drug company that developed the drug (the manufacturer) gives the drug company the sole right to sell the drug while the patent is in effect

Patent Protection:

Patent Protection When the patents on a brand-name drug near expiration, drug companies that want to manufacture a generic can apply to the FDA to sell a generic version of the drug.

Generic Drug Review:

Generic Drug Review Much the same as new, brand name drug review 8 major parts

Generic Drug Review:

Generic Drug Review FDA-approved generic drugs must have same active ingredient(s) same labeled strength same dosage form same administration

Generic Drug Review:

Generic Drug Review The drug company must show the generic drug is “bioequivalent” to the brand-name drug. active ingredient works in the same way active ingredient works in the same amount of time

Generic Drug Review:

Generic Drug Review The generic drug’s labeling must be basically the same as that of the approved brand-name drug.

Generic Drug Review:

Generic Drug Review 4. The drug company must: fully document the generic drug’s chemistry, manufacturing steps, and quality control measures detail each step of the process

Generic Drug Review:

Generic Drug Review 5. The raw materials and the finished product must meet USP specifications, if these have been set. USP-United States Pharmacopeia

Generic Drug Review:

Generic Drug Review The drug company must: show that its generic drug maintains stability as labeled before it can be sold continue to monitor drug’s stability

Generic Drug Review:

Generic Drug Review The drug company must: comply with federal regulations for current good manufacturing practices give a full description of the facilities it uses to manufacture, process, test, package, label, and control the drug

Generic Drug Review:

Generic Drug Review 8. Inspection at the proposed manufacturing site ensures that the firm: is capable of meeting commitments of the application can manufacture the product consistently

FDA Requirements for Brand-Name and Generic Drugs:

Brand Name Drug Generic Drug For reformulations of a brand-name drug or generic versions of a drug, FDA reviews data showing the drug is bioequivalent to the one used in the original safety and efficacy testing. FDA evaluates the manufacturer's adherence to good manufacturing practices before the drug is marketed. FDA reviews the active and inactive ingredients used in the formulation before the drug is marketed. FDA reviews the actual drug product. FDA reviews the drug's labeling. Manufacturer must seek FDA approval before making major manufacturing changes or reformulating the drug. Manufacturer must report adverse reactions and serious adverse health effects to the FDA. FDA periodically inspects manufacturing plants. FDA monitors drug quality after approval. FDA Requirements for Brand-Name and Generic Drugs

What You Want to Know About Generic Drugs:

What You Want to Know About Generic Drugs What the FDA and the administration are doing to make more generic medicines available to the American public

Making More Generics Available:

Making More Generics Available Hatch-Waxman Act, or the Patent Term Restoration Act of 1984 President’s 2003 budget increased FDA’s funding to speed up generic drug reviews (more reviewers, etc.)

Making More Generics Available:

Making More Generics Available “Improving Access to Generic Drugs” initiative new regulatory processes to reduce time and cost of generic drug approvals

Making More Generics Available:

Making More Generics Available “Improving Access to Generic Drugs” initiative (continued) enhanced public and professional education

Making More Generics Available:

Making More Generics Available “Improving Access to Generic Drugs” initiative (continued) enhanced scientific study of generic drugs

Making More Generics Available:

Making More Generics Available C. “Improving Access to Generic Drugs” initiative (continued) enhanced monitoring of the safety of generic drugs

Blue Cross Blue Shield of Michigan Billboards:

Blue Cross Blue Shield of Michigan Billboards

Making More Generics Available:

Making More Generics Available D. FDA’s generic drug Final Rule, 8-18-03 seeks to close legal loopholes in the Hatch Waxman Act that delay generic drug approval

Making More Generics Available:

Making More Generics Available D. FDA’s generic drug Final Rule, 8-18-03 (continued) implements an FTC recommendation to tighten the patent submission and listing process

Making More Generics Available:

Making More Generics Available D. FDA’s generic drug Final Rule, 8-18-03 (continued) clarifies the types of patents that must be submitted to the FDA

Making More Generics Available:

Making More Generics Available E. House and Senate passed a bill, “Greater Access to Affordable Pharmaceuticals Act” complements FDA’s final rule. FDA is working with Congress

Myths and Facts about Generic Drugs:

Myths and Facts about Generic Drugs

Myths and Facts about Generic Drugs:

Myths and Facts about Generic Drugs MYTH #1 Generics are not as safe as brand-name drugs.

Myths and Facts about Generic Drugs:

Myths and Facts about Generic Drugs FACT #1 Generics use the same ingredients, and work the same in the body have the same risk-benefit profile

Myths and Facts about Generic Drugs:

Myths and Facts about Generic Drugs MYTH #2 Generics are not as potent as brand-name drugs.

Myths and Facts about Generic Drugs:

Myths and Facts about Generic Drugs FACT #2 Generic drugs have the same quality, strength, purity and stability.

Myths and Facts about Generic Drugs:

Myths and Facts about Generic Drugs MYTH #3 Generics take longer to act in the body.

Myths and Facts about Generic Drugs:

Myths and Facts about Generic Drugs FACT #3 The generic drug delivers the same amount of active ingredient in the same time as the original drug.

Myths and Facts about Generic Drugs:

Myths and Facts about Generic Drugs MYTH #4 Brand-name drugs are made in modern manufacturing facilities, and generics are often made in sub-standard facilities.

Myths and Facts about Generic Drugs:

Myths and Facts about Generic Drugs FACT #4 Sub-standard facilities are not permitted by the FDA.

What you want to know about Generic Drugs:

What you want to know about Generic Drugs Contact your physician, pharmacist, or insurance company for more information about your generic drugs.