Isaac Smith


Isaac is a highly accomplished healthcare professional with over 13 years of experience in healthcare administration, medical billing and coding, and compliance. He holds several AAPC specialty certifications and has a bachelor’s degree in Health Administration. He worked previously at a large multi-physician family care and occupational health practice with two locations in northwestern PA and now works for Medcare MSO in the ICD-10 Editorial department to write articles about medical coding. He enjoys sharing his knowledge and experience as a certified PMCC instructor. He has authored many articles for healthcare publications and has been a featured speaker at workshops and coding conferences across the country.

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Some Drugs That Improve Price Competition Fall Through The Cracks Of FDA User Fees

Some Drugs That Improve Price Competition Fall Through The Cracks Of FDA User Fees

Americans are increasingly concerned about rising drug prices. FDA user fees affect drug pricing competition, which is often overlooked. FDA user fees fund regulatory activities and encourage timely reviews and approvals, but some drugs that could improve price competition may fall through the cracks. Thus, smaller pharmaceutical companies and other generic drug or biosimilar manufacturers may face longer approval times or other regulatory hurdles, limiting their price competitiveness. FDA user fees and drug pricing competition will be discussed in this article.