An Official statement has been released by the United States Food and Drug Administration (FDA) regarding to their recent press reports about the product quality issues and ongoing efforts to maintain the quality of generic drugs manufactured both in the US and other countries.
The joint statement, authored by FDA Commissioner Dr.Gottlieb Scott and Center for Drug Evaluation and Research (CDER) Ongoing Director Dr Janet Woodcock, is a response to recent press reports suggesting that some of the generic drugs are of lower quality and higher prices equal to the branded ones. Further added to the statement about the serious flawed into the manufacturing of generic drugs used by the US Citizens.
FDA advises to use the statement to tell the general public how they protect the quality and efficacy of generic drugs to a particular level, addressing errors in popular news reports and public generals. It particularly refers to reports of side effects caused by generic versions of cholesterol-lowering drug usage. The statement goes on to say there is no evidence that generic drugs usage was more likely to be associated with side effects than the reference product, It is all about public health and wealth safety and security.
To address the concerns about how FDA seriously supervises generic drugs manufacturing, the statement makes four key points:
1. Generic drugs are equally as safe and effective as branded drugs
• A generic drug contains the same primary active ingredient as their brand-name had.
• US FDA generic drugs testing program conducts a rigorous assessment of all generic drugs before they are getting approved and comes to the market with all positive, long-term benefits, and negative side effects
• After generic drugs getting approved, FDA always monitor their approved generic drug products to ensured that they are safe and effective to accomplish all levels of the supply chain.
2. FDA performs extensive product analysis to ensure the product quality and safety of a particular drug throughout its lifecycle.
• FDA always monitors many type of data sources to determine the safety and quality of generic drugs.
• FDA always monitors the manufacturer generic drugs quality, facility and test at regular interval inspection of products.
• Manufacturers must inform to FDA of any kind of changes to their manufacturing process or facilities in product up gradation.
• A Multidisciplinary team issued by FDA investigates the proper reporting of adverse products reviews, trials made on products and healthcare responses.
3. FDA also inspects the product facilities in overseas countries, especially in the country like China and India,as most of the pharma manufacturers are from this countries.
• FDA also maintains its global vigilance by using a risk-based inspection strategy for generic drugs.
• FDA strategy also made serious inspections on based of various factors including generic drugs compliance products history, recall product trends, curable time since last inspection up gradation as per records and main risk level of the generic drug being manufactured in different countries.
4. FDA takes action when issues are found
• In 2018, the authority CDER issued 120 warning letters (compared to just 29 in 2016).
• After an action inspection, founded issues are proper evaluated and classified into various general and press. Response being also evaluated and monitored by field investigator.
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