FDA ENSURES SAFETY AND EFFECTIVENESS:
Today, almost half of all prescriptions are filled with generic drugs. So they are now become vital part of health care industry and human health. FDA requires Generic drugs should ensure safety and effectiveness by scientific reviews. Health care costs and low-cost generic drugs are very important and related factors to each other. The low cost of generics has broad benefits for the public and they are easily available at pharmacies. A generic drug is similar to a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. Food and Drug Administration has a backlog of more than 800 applications to bring new generic products to the market — an all-time high.
As many people including physician, pharmacist are waiting for more generics to be approved, Generic Drugs agencies face frustration about the backlog. According to Experts, fewer generic drugs will be available to consumers in the years ahead than the industry is ready and able to provide.FDA requires generic drugs agency should provide the same quality, strength, purity and stability as brand-name drugs without additional money and reviewers. This also reduces the cost of development.
An ever-growing number of generics are essential factor for controlling the cost to the government and seniors of the new Medicare prescription drug program. According to recent report, slowdown in the rate of prescription drug spending that was credited. Due to growing use of generics, more than half of all prescriptions are filled with Generic drugs. A generic drug, which comes on the market after another drug’s patent expires and must have the same active ingredients as the drug it mimics, usually costs 60 to 90 percent less than the brand-name version. The cost drops the most with the first generic alternative to a brand-name drug, and it falls more as each new competitor reaches the market.
FDA requires that all drugs be safe and effective as FDA gives first priority to “Patient’s Protection”. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices and guidelines. FDA won’t permit drugs to be made in substandard facilities and low criteria. FDA conducts about 3,500 inspections a year to ensure standards are met and guidelines they provided. A generic drug must duplicate the active ingredient of brand name drug. But colors, flavors, and certain other inactive ingredients may vary. But functioning and effectiveness of Generic Drugs remains the same as brand name drugs.
Generic drugs are less expensive because generic manufacturers don’t have the investment costs of the developer of a new drug. Manufacturers don’t need the same development costs; they are free to sell their product at substantial discounts as they want. Also, once generic drugs are approved, there is greater competition, which down the price. The cost drops the most with the first generic alternative to a brand-name drug, and it falls more as each new competitor reaches the market and it goes on.