Prescription Drugs: Describe and discuss the rationale for considering the pharmaceutical industry a public policy dilemma.
Ans) Pharmaceutical companies are heavily regulated to ensure they are in compliance with federal safety laws.
- In the United States, the Food and Drug Administration (FDA) ensures that new drugs are rigorously tested for safety, efficacy and minimal side effects.
- A pharmaceutical company, or drug company, is a commercial business licensed to research, develop, market and/or distribute drugs, most commonly in the context of healthcare. They can deal in generic and/or brand medications. Drug development is considered a costly and intensive process.
- The activist government policies of the past few decades have been a major factor contributing to the adverse trends observed in the case of pharmaceutical innovation.
- Public policy in pharmaceuticals has been characterized by increasingly stringent regulatory controls, shorter effective patent terms, and increasing encouragement of generic product usage. While all of these policies have been well-intended, in combination, they have produced significant unintended adverse side effects on the drug innovational process.
- They have contributed to the present situation of fewer independent domestic sources of innovation and fewer annual new drug entity introductions. This has occurred despite a steadily expanding base of rich, scientific, opportunities emerging from basic research endeavors.
- Outside the support of basic research, there has been very little attention given by policymakers to the effects of government policy on industrial innovation.
- This is a particularly myopic and sub-optimal approach to public policy. Historically, new drug innovations have played a central role in medical progress.
- Furthermore, new drugs have frequently replaced much more costly and less effective medical treatments, leading to substantial resource saving in medical expenditures. Hence, economic and health gains generally have been realized in a complementary fashion.
- It is now time to reform our regulatory and other industrial policies to insure that a conducive atmosphere for vigorous competition in new drug innovation will hold in the years ahead.
Prescription Drugs: Describe and discuss the rationale for considering the pharmaceutical industry a public policy dilemma.
Prescription Drugs: Describe and discuss the structure of the pharmaceutical industry.
Prescription Drugs: . Describe and discuss the development of new drugs by the U.S. pharmaceutical industry.
Prescription Drugs: Describe and discuss the rationale for FDA regulation of drugs.
Prescription Drugs: Describe and discuss the main reasons for the ongoing increases in pharmaceutical expenditures in the United States.
Prescription Drugs: Describe and discuss the consequences of price controls on prescription drugs.
Prescription Drugs: Describe and discuss the political attractiveness of price controls on prescription drugs.
The US pharmaceutical industry spent $6.4 billion on advertising prescription drugs directly to consumers in 2016. Since 1962 these ads have been regulated by the Food and Drug Administration (FDA) to ensure that they are not false or misleading. The United States and New Zealand are the only two countries where direct-to-consumer (DTC) advertising of prescription drugs is legal. Why should prescription drugs be advertised directly to consumers? Write at least five reasons.
Prescription Drugs: Describe and discuss the history of prescription drug regulation.
Prescription Drugs: Describe and discuss why prescription drugs are expected to be priced lower overseas than US.
Prescription Drugs: Describe and discuss the FDA’s guidelines for safety and efficacy.