Pharma Regulation for Generics
There has been much argument about whether generic drugs are as effective as regular drugs or not. In the United States, all drugs have to be approved by the US Federal Food and Drug Administration (FDA). This is true whether the product is a brand name or generic versions of the drug. According to the director of the FDA’s Office of Generic Drugs, the standards which determine a drug’s quality are the same whether or not they are brand name. There are still many myths about generic drugs even though the FDA maintains the same strict guidelines for them.
How is a generic drug approved by the FDA?
Just like any kind of new product, new drugs are developed under a protection provided by a patent. This protects the investment being made in the drug and gives the company the sole rights to sell the drug as long as the patent is in effect. When a patent or any other type of exclusivity on a brand name drug reaches its expiration, then other manufacturers can make application to the FDA to sell a “generic” version. The vast majority of the way the FDA reviews generic and brand name drugs is relatively the same.
Reviewing Applications for Generic Drugs
In order for a firm to make an application for a generic drug, there has to already be a brand name drug that has FDA approval. The generic drug has to contain the same active ingredients and the same strength as the brand name being referenced. And it also has to be administered the same way such as taken as a pill or given by injection. The manufacturer must show how the generic drug is an “equivalent” to the brand name product. The generic drug’s labeling has to be basically the same as the brand name equivalent. The firm has to be able to completely document the generic drug’s manufacturing steps, chemistry and quality control measures. Every step of this process must be provided to the FDA in detail. After the drug has reached the market the firm has to continue to monitor the stability of the drug. IF the firm is making a sterile drug, then they must also submit data ensuring its sterility. They must also provide the FDA with a full description of the facility which will manufacture, test, process, package, control and label the product. In order to ensure full pharmaceutical compliance, the facility will have to undergo a thorough inspection. This is to ensure that the firm is able to meet the commitments as they were laid out in the application. The FDA will conduct this investigation to ensure that the manufacture of the product will remain consistent.
FDA and Regulating Generic Medications
One of the basic differences in the regulatory practices between brand name products and their generic equivalents is that generic drugs do not have to make any changes in their labeling. Presently, generic drugs cannot make any changes to the labels on the products; they must use the same label and information as the brand name products. The trouble is that since the manufacturers do not create the label, they cannot be held liable for what it contains like brand name manufacturers can. The FDA Rule may soon become law and at that time generic drug makers will have to provide their own labels and then will run the same risks as the companies which produce brand name products. The FDA is trying to remedy a situation in which consumers are barred from bringing lawsuits against generic drug makers. This offers some protection for generic product manufacturers since the Court’s position suggests that since they are forced to use the same label by law, they cannot be sued for failure to warn.
With the increased number of manufacturers of generic drugs, they should begin planning for more regulations. It is true that every business is fully responsible for the goods or services that they provide for sell to the public and the FDA has begun to impose the same responsibilities on generic companies as are imposed on those who make brand name products. Until the FDA regulations tighten up, it is likely that the public may view generic products as less safe than brand name products.
How is a generic drug approved by the FDA?
Just like any kind of new product, new drugs are developed under a protection provided by a patent. This protects the investment being made in the drug and gives the company the sole rights to sell the drug as long as the patent is in effect. When a patent or any other type of exclusivity on a brand name drug reaches its expiration, then other manufacturers can make application to the FDA to sell a “generic” version. The vast majority of the way the FDA reviews generic and brand name drugs is relatively the same.
Reviewing Applications for Generic Drugs
In order for a firm to make an application for a generic drug, there has to already be a brand name drug that has FDA approval. The generic drug has to contain the same active ingredients and the same strength as the brand name being referenced. And it also has to be administered the same way such as taken as a pill or given by injection. The manufacturer must show how the generic drug is an “equivalent” to the brand name product. The generic drug’s labeling has to be basically the same as the brand name equivalent. The firm has to be able to completely document the generic drug’s manufacturing steps, chemistry and quality control measures. Every step of this process must be provided to the FDA in detail. After the drug has reached the market the firm has to continue to monitor the stability of the drug. IF the firm is making a sterile drug, then they must also submit data ensuring its sterility. They must also provide the FDA with a full description of the facility which will manufacture, test, process, package, control and label the product. In order to ensure full pharmaceutical compliance, the facility will have to undergo a thorough inspection. This is to ensure that the firm is able to meet the commitments as they were laid out in the application. The FDA will conduct this investigation to ensure that the manufacture of the product will remain consistent.
FDA and Regulating Generic Medications
One of the basic differences in the regulatory practices between brand name products and their generic equivalents is that generic drugs do not have to make any changes in their labeling. Presently, generic drugs cannot make any changes to the labels on the products; they must use the same label and information as the brand name products. The trouble is that since the manufacturers do not create the label, they cannot be held liable for what it contains like brand name manufacturers can. The FDA Rule may soon become law and at that time generic drug makers will have to provide their own labels and then will run the same risks as the companies which produce brand name products. The FDA is trying to remedy a situation in which consumers are barred from bringing lawsuits against generic drug makers. This offers some protection for generic product manufacturers since the Court’s position suggests that since they are forced to use the same label by law, they cannot be sued for failure to warn.
With the increased number of manufacturers of generic drugs, they should begin planning for more regulations. It is true that every business is fully responsible for the goods or services that they provide for sell to the public and the FDA has begun to impose the same responsibilities on generic companies as are imposed on those who make brand name products. Until the FDA regulations tighten up, it is likely that the public may view generic products as less safe than brand name products.