FDA Pushes for Prescription Drugs to Become Over-the-Counter
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 hours ago
0mins
Should l Buy GILD?
Source: CNBC
- Policy Advocacy: FDA Commissioner Marty Makary stated in Washington that the agency plans to push for more prescription drugs to become over-the-counter (OTC) this year, aiming to improve drug accessibility and reduce healthcare costs, which could allow patients to obtain basic safe medications without a doctor's visit.
- Regulatory Streamlining: Legislation passed by Congress in November simplifies the regulatory process for transitioning prescription drugs to OTC status, including full, conditional, and partial switch pathways, which is expected to accelerate drug availability and enhance patient convenience in medication access.
- Increased Transparency: Makary emphasized that OTC sales would bypass insurers and pharmacy benefit managers, potentially lowering drug prices and increasing transparency, with cash prices for OTC medications possibly being lower than patients' copays for prescription drugs, thereby alleviating financial burdens on patients.
- Industry Pushback: The pharmaceutical industry has raised concerns about this policy, arguing that OTC drugs may not be covered by insurance, leading to higher costs for patients, and that the FDA lacks authority over drug pricing, necessitating thorough consultations with manufacturers before any transitions.
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Analyst Views on GILD
Wall Street analysts forecast GILD stock price to fall
19 Analyst Rating
16 Buy
3 Hold
0 Sell
Strong Buy
Current: 155.270
Low
105.00
Averages
137.88
High
154.00
Current: 155.270
Low
105.00
Averages
137.88
High
154.00
About GILD
Gilead Sciences, Inc. is a biopharmaceutical company. It is engaged in advancing medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. It is focused on discovering, developing, and delivering medicines to address unmet medical needs in virology, oncology, and other therapeutic areas. Its portfolio of marketed products includes Biktarvy, Genvoya, Descovy, Complera/Eviplera, Symtuza, Truvada, Stribild, Sunlenca, Epclusa, Vemlidy, Harvoni, Viread, Livdelzi, Veklury, Yescarta, Tecartus, Trodelvy, AmBisome, and Letairis. Its product candidates include Bulevirtide, Lenacapavir, Axicabtagene ciloleucel, Sacituzumab govitecan-hziy, and others. It also develops the HB-400 program and the HB-500 program. It develops therapies that are intended to provide functional cures for hepatitis B virus and human immunodeficiency virus-1. It has a cancer program, namely TREX1. It operates in more than 35 countries worldwide.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Milestone Payments: The agreement allows Genhouse to potentially receive up to $1.45 billion in milestone payments, which not only provides financial support to Genhouse but may also accelerate the development of GH31, enhancing its market competitiveness.
- Global Development Responsibility: Gilead will be responsible for the global development, regulatory submissions, and future commercialization of GH31, reflecting Gilead's confidence in the drug and potentially facilitating its rapid market introduction worldwide.
- Clinical Approval: GH31 has received IND approval in both the US and China, laying a solid foundation for Gilead's subsequent development and market promotion, further strengthening its positioning in the global oncology treatment market.
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- Policy Advocacy: FDA Commissioner Marty Makary stated in Washington that the agency plans to push for more prescription drugs to become over-the-counter (OTC) this year, aiming to improve drug accessibility and reduce healthcare costs, which could allow patients to obtain basic safe medications without a doctor's visit.
- Regulatory Streamlining: Legislation passed by Congress in November simplifies the regulatory process for transitioning prescription drugs to OTC status, including full, conditional, and partial switch pathways, which is expected to accelerate drug availability and enhance patient convenience in medication access.
- Increased Transparency: Makary emphasized that OTC sales would bypass insurers and pharmacy benefit managers, potentially lowering drug prices and increasing transparency, with cash prices for OTC medications possibly being lower than patients' copays for prescription drugs, thereby alleviating financial burdens on patients.
- Industry Pushback: The pharmaceutical industry has raised concerns about this policy, arguing that OTC drugs may not be covered by insurance, leading to higher costs for patients, and that the FDA lacks authority over drug pricing, necessitating thorough consultations with manufacturers before any transitions.
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- Milestone Payments: The agreement allows Genhouse to potentially receive up to $1.45 billion in milestone payments, which not only provides financial support to Genhouse but may also accelerate the development of GH31, enhancing its market competitiveness.
- Global Development Responsibility: Gilead will be responsible for the global development, regulatory submissions, and future commercialization of GH31, reflecting Gilead's confidence in the drug and potentially facilitating its rapid market introduction worldwide.
- Clinical Approval: GH31 has received IND approval in both the US and China, laying a solid foundation for Gilead's subsequent development and market promotion, further strengthening its positioning in the global oncology treatment market.
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- Policy Advocacy: FDA Commissioner Marty Makary stated in Washington that the agency plans to push for more prescription drugs to become over-the-counter (OTC) this year, aiming to improve drug accessibility and reduce healthcare costs, which could allow patients to obtain basic safe medications without a doctor's visit.
- Regulatory Streamlining: Legislation passed by Congress in November simplifies the regulatory process for transitioning prescription drugs to OTC status, including full, conditional, and partial switch pathways, which is expected to accelerate drug availability and enhance patient convenience in medication access.
- Increased Transparency: Makary emphasized that OTC sales would bypass insurers and pharmacy benefit managers, potentially lowering drug prices and increasing transparency, with cash prices for OTC medications possibly being lower than patients' copays for prescription drugs, thereby alleviating financial burdens on patients.
- Industry Pushback: The pharmaceutical industry has raised concerns about this policy, arguing that OTC drugs may not be covered by insurance, leading to higher costs for patients, and that the FDA lacks authority over drug pricing, necessitating thorough consultations with manufacturers before any transitions.
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