FDA Documents - Provided by FOI Services
Introduction to Patented Drugs
Patents for pharmaceuticals have some very special considerations. The 1984 Drug Price Competition and Patent Term Restoration Act (generally known as the Waxman-Hatch Act) established provisions beginning the practice of marketing generic drugs, but also allowed for extending patents on new drug products through periods of extended market exclusivity. This exclusivity helps patent holders make up for time ‘lost’ during United States Food and Drug Administration review of their product and is in addition to the up to 20 years of protection that comes with a patent. Competitors are barred from submitting their Abbreviated New Drug Applications (ANDAs) for generic forms of patented products during the exclusivity periods.
New drugs involving New Molecular Entities (drugs whose active ingredients have never been approved before) receive exclusivity for five years. (An exception can be made which shortens the exclusivity to four years if a certification is included which states that the patent is invalid or will not be infringed.) New drugs involving reports of new clinical investigations essential to approval can receive exclusivity for three years. Likewise, a supplement to a New Drug Application (NDA) can receive three-year exclusivity for its approved change if the supplement involves new clinical investigations that were essential to approval. Not all drug products qualify for exclusivity under Waxman-Hatch, however. The provisions of the Act only apply to products approved after September 24, 1984 which meet one of the three requirements outlined in the Code of Federal Regulations, where the full text of the Act is presented. Antibiotics are also excluded. The documents that are produced by the regulatory process of FDA’s review of the safety and effectiveness of new drugs offer a valuable adjunct to the information offered by the patent itself. For example, the chemistry and manufacturing processes are examined, clinical trials critiqued, and correspondence with the manufacturer recorded.
In a special arrangement for its customers, REEDFAX is pleased to make available many of these regulatory documents in conjunction with the patent itself. You’ll see from the documents themselves that these are not neat published documents available in any library. Rather, these documents have been acquired using the Freedom of Information Act by FOI Services, Inc. The documents, literally copies of records from the desk drawers of FDA staff, can be handwritten, difficult to read, and have identifying information such as a date missing – just like some of the files in your cabinets. In addition, these documents, as required by the US Freedom of Information Act, are purged of confidential information, such as commercial or privacy concerns.Also, no documentation is available before the product is approved by FDA. That said, you’ll never find better background information for learning about how a particular innovator drug came to market.
Samples of typical documents released on New Drug Applications (NDAs) are available below.
Relevant FDA documents will be displayed when pharmaceutical patents are entered into the Order Center. You can select any documents wanted and they will be added to the order cart.
