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Dkonara921 replied to the topic Regulations with quality in the forum Quality Control and Quality Assurance 7 years ago
The FDA can unintentionally cause quality to be lowered through its regulations because companies may be forced to work around them. There may be loopholes associated with certain regulations and companies can use that to either raise prices for products and lower quality because of the legal liability. Many big companies(e.g. Johnson&Johnson) outsource their drug manufacturing facilities to other countries because they cannot afford to comply with US regulations on their product. Regulations are well-intentioned but they can have adverse consequences. If companies move to other countries that have less regulation, then there will be no point in the government implementing regulations as businesses will get away from such influences by outsourcing. Many FDA regulations cause artificial increases in drug prices. One such regulation would be that in order for a drug to get approved to the market, it has to be both safe and perform the desired affect on the patient. If the FDA allowed drugs that were safe but didn’t work, then prices can fall dramatically. Even if quality is enhanced by the FDA regulations, the quality won’t matter to customers if prices are too high.