The Changing Economics of Medical Technology (1991) / Chapter Skim
Currently Skimming:
Appendix A: The Impact of Regulation and Reimbursement on Pharmaceutical Innovation
Appendix A: The Impact of Regulation and Reimbursement on Pharmaceutical Innovation
Pages 169-180
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 169... ...
Unfortunately, there are no good data with which to evaluate the impact of public policy on pharmaceutical innovation. I will rely more on qualitative evidence and observations, and I will especially consider regulatory and reimbursement policies, because in my judgment they have great impact on the industry.
|
From page 170... ...
The FDA has laboratory practice regulations that dictate the way in which animal studies must be conducted if they are to be considered for product approval, but these probably add very little to the length and cost of the overall drug development process. Beyond this is the much more fundamental issue of how much and what kind of animal studies need to be done before an investigator can begin testing in humans and how much animal work needs to be done to receive
|
From page 171... ...
After completing preclinical testing, a manufacturer files an IND with the FDA to receive permission to begin testing in humans. The IND contains all the information known about the compound, including its chemical structure, proposed mechanism of action, stability and manufacturing information, the methods and results of preclinical laboratory and animal studies, and the proposed plans, methods, and investigators for clinical trials.
|
From page 172... ...
Researchers at the NCI said they would never go ahead with changes without getting FDA agreement, and many in the pharmaceutical industry do the same thing. When an investigator goes from a Phase I to a Phase II clinical trial, it may take 6 months to a year to get agreement from the FDA on the protocol.
|
From page 173... ...
The large range is partly explained by the discretionary nature of the clinical development stage. For example, there are no uniform requirements on the number of Phase III trials, which are the largest, most expensive, and most time consuming.4 If the FDA requires two or three Phase III studies, it is going to take a long time for your NDA.
|
From page 174... ...
The FDA has established a priority system based upon its assessment of a drug's chemical novelty and potential treatment benefit over existing therapies.6 Internal FDA review of pending NDAs results in an inventory that lists drugs from most important to least important. The FDA priority system does not coincide with the economic needs of companies or the economic needs of the innovation process.
|
From page 175... ...
In fact, a new phenomenon has been emerging recently: drug companies receive FDA approval but decide not to market the compound because it has become obsolete while awaiting official clearance. How could we change this system?
|
From page 176... ...
As a result, expensive formal studies are not needed. One area worth considering in terms of economic impact on the pharmaceutical innovation process is the use of supplemental NDAs to gain approval for new uses of approved drugs, changes in the drug label, changes in manufacturing procedures, or other changes in the original NDA.
|
From page 177... ...
Congress passed a statute that gave the pharmaceutical industry two alternatives: get rid of research or raise prices to finance research. Generic competition has caused drug companies to raise prices while they still have marketing exclusivity, and these higher prices are what finance drug research.
|
From page 178... ...
Payers usually disagree vigorously with such a characterization, so let me give three scenarios: use of an unapproved drug in a clinical investigation, use of an unapproved drug for treatment outside a clinical investigation (i.e., compassionate use of an investigational drug) , and use of an approved drug for an unapproved purpose.
|
From page 179... ...
The Center for Devices and Radiological Health regulates medical devices and radiological products. There is also a Center for Food Safety and Applied Nutrition that regulates foods and cosmetics and a Center for Veterinary Medicine that regulates animal food and drugs.
|
From page 180... ...
4. Phase III trials usually involve 1,000 to 3,000 patients and are carried out at several different medical centers.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.