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Abbreviated New Drug Applications, state laws, and more.
According to the FDA, 9 out of 10 prescriptions filled in the U.S. are for generic drugs. The FDA’s Office of Generic Drugs (OGD), falling under the umbrella of the Center for Drug Evaluation and Research, is in charge of the generic drug regulatory process. Generic drugs must contain the same active/key ingredient, have the same strength, and use the same dosage form and the same route of administration as their brand name product. Generic drugs may have minor differences from the brand such as different inactive ingredients. All of these measures also ensure that generic drug treatments are more affordable to patients.
Abbreviated New Drug Application (ANDA)
The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, allows the FDA to approve generic drugs through the ANDA. Generic drug applications do not need to include clinical trials to demonstrate safety and efficacy. Instead, the Hatch-Waxman Amendments established that the generic product must be bioequivalent to the brand product through examination of the drugs in healthy volunteers. All approved products are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. The first generic drug company to submit their ANDA with a provision challenging a patent receives a180-day generic drug exclusivity. This means it’s the only generic product on the market without competition by another company. After the 180-day exclusivity period finishes, other generic products can enter the market and the drug prices decrease.
Up Next: State Generic Drug LawsState Generic Drug Laws
State laws dictate whether pharmacists can substitute a brand name medication with a less expensive generic drug when dispensing a prescription. As of May 3, 2019 based on data from the National Conference of State Legislatures, the following states and one territory require a pharmacist to substitute with a generic drug if all other prescription requirements are met: Florida, Kansas, Kentucky, Massachusetts, Minnesota, Nevada, New Jersey, New York, Pennsylvania, Puerto Rico, Vermont, and Washington. However, in Oklahoma, a pharmacist is not permitted to substitute without authorization from both the physician and patient.
Up Next: FDA Drug Competition Action Plan
FDA Drug Competition Action Plan (DCAP)
In 2017, the FDA announced the DCAP to encourage market competition for generic drugs and enhance the generic drug review process. There is also a plan in place to ensure timely review of complex generic drug products. The DCAP also intends to reduce “gaming” to delay generic drug approval. Ultimately, the goal is to remove barriers to generic drug development so that patients have access to medications.
Up Next: Authorized GenericsAuthorized Generics
Authorized generics are the same as the brand-name drug, but it does not use the brand name on the label, making it different than a generic drug. Additionally, authorized generics may be marketed by the brand name drug company or another company with the manufacturer’s approval. Companies may also sell the authorized generic at a lower cost than the brand name. Pharmacists should know that authorized generics are not listed in the FDA’s Orange Book since they are marketed under the brand name drug’s NDA. The FDA publishes an electronic list of authorized generics that is updated quarterly.
Up Next: Counseling Pearls
Pharmacists should educate patients that generic drugs are just as safe and effective as the brand products and can result in significant cost savings. Additionally, generic drugs deliver the same amount of active ingredient in the same time as the brand product. Generic products marketed by different companies can have differences in size, shape, and color, so it is important to let patients know this when dispensing the medication. Patients may be concerned that they are not receiving the correct drug if they are used to a specific generic manufacturer, so it’s always important to double check that they have the right medication.