Approval of pharmaceuticals

In Chapter 8, professor J.L. Pinto Prades of Pompeu Fabra University and X. Badla Llach of the Health Outcomes Research Unit at Santa Creu i Sant Pau Hospital take a look at the potential contribution of economic evaluation to the regulation and control of public spending on pharmaceuticals. The authors focus on observing how economic evaluation can be used in pharmaceutical policy. To this end, they distinguish and analyse the potential this instrument has in six distinct areas the approval of pharmaceuticals by health... 

Approval of pharmaceuticals by health authorities The decision we are faced with here is whether a particular drag should be on the market or not. Normally governments decide whether to approve or reject the marketing of drugs solely on the basis of effectiveness and safety considerations. Should/can economic evaluation play a part in this ... 

This example is very simple and restrictive, but it is useful to illustrate the idea that economic evaluation can help to regulate the approval of pharmaceuticals. It also shows that one of the lessons to be leamt from applying the rules of economic evaluation is that the way dmg approval is regulated should change from one dmg to another, depending on the costs and benefits of each option. 

Patents which are related to pharmaceuticals can provide a significantly shorter effective protection for the resulting products, since a considerable time of the patent life may pass before all conditions for the market approval of pharmaceutical products are fulfilled. For such cases, some countries extend the patent duration of pharmaceutical patents to cover or offset the time which is lost during the registration of the related product. Possible extensions are equivalent to the time required to get market approval but are not meant to compensate for time losses associated with the technical hurdles of product development. 

Storey, S. Challenges with the development and approval of pharmaceuticals for fish. AAPS J. in press. 

A new law and decree came into effect in Brazil in January 1977. It established the rules for submission and approval of pharmaceutical products. DIMED/ Secretaria de Vigilancia Seinitaria issue some specific norms for dossier submission to the health authorities for certain products such as controlled products, over-the-counter (OTC) products, etc. 

In response to the country s major public health problems, a mechanism for speeding up the approval of pharmaceutical products of certain therapeutic classes has been established. The criteria for consideration will focus on the severity of the disease and the absence of satisfactory alternative therapy which will be considered for medical risk-benefit judgment in making the final decision on the approval of new pharmaceutical products. At present, the pharmaceutical products under the fast-track scheme will cover the medicines for serious or life-threatening sicknesses such as anti-HIV, anticancer, and pharmaceutical products designated as orphan drugs which are entitled to priority review and approved by the... 

The US regulates animal trials mainly through the requirement to inform the authorities before non-approved veterinary pharmaceuticals are shipped to trial sites. Depending on whether it is classified as a drug or a biologic, information must be submitted to either the FDA Center for Veterinary Medicines (CVM) or the United States Department of Agriculture (USDA) Center for Veterinary Biologies (CVB). 

New pharmaceutical form approved 6 years after approval of the original product. 

The generic manufacturer may not place a copy of either the original product or the new pharmaceutical form on the market for a period of 11 years after the approval of the original product (i.e. 10 years + 1 year added to the global market exclusivity period, because of new indications). 

The generic manufacturer may not submit an ANDA for the new pharmaceutical form until 11.5 years after approval of the original product (i.e. 5 years from the date of approval of the new form + 0.5 years for the paediatric application). 

The current Good Manufacturing Practice (cGMP) regulations are guidelines that FDA requires a pharmaceutical manufacturer to meet. Compliance with the cGMPs is a prerequisite for the approval of NDAs, INDs, and antibiotic forms. General areas in which... 

F-D-C Reports Pharmaceutical Approvals Monthly. Pharmaceutical Approvals Monthly [99] provides coverage of U.S. drug approvals at the clinical level and includes the most recent FDA list of NDA approvals (originals, supplementals, and ANDAs). This specialized monthly also focuses on new drugs that have either been recently approved or... 

Contracting out of activities previously only conducted in-house is already becoming quite common and will probably continue to develop. In the past a so-called full-service pharmaceutical company took direct responsibility for all the activities required for the formulation, manufacture, quality control, and regulatory approval of its drug products. Nowadays the use of specialist contract houses to perform activities such as formulation, analytical methods development, manufacture of clinical trials supplies, supervision of the assembly of an NDA, postmarketing surveillance, and even troubleshooting may be contracted for even by some of the largest companies. 

Proposal to Withdraw Approval of Two New Drug Applications and One Abbreviated New Drug Application Terfenadine, Hoechst Marion Rousssel, Inc and Baker Norton Pharmaceuticals, Fed Regist., Docket No. 96N-0512, 1997, 1998. Part 216 Pharmacy Compounding, Drug Products Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness, Cite 216.24. 

If a government tightens up its drug approval policy it will have fewer type II errors but more type I errors, and vice versa. Therefore, an ideal drag approval policy should take into account both the costs and the benefits of a stricter or less strict policy when approving a pharmaceutical. Insofar as the costs and benefits stated above are important factors in the decision to approve or reject a drug, the role of economic evaluation is clear. 

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