MCPHS University International Center for Pharmaceutical Economics and Policy American Public Health Association Boston Nov 5 2013 Presenter Disclosures 1The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 ID: 914613
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What Do We Know About the Mechanism of Action of Drugs in the Different Drug Classes? Assessment of Pharmaceuticals Approved by the FDA between 1980 and 2012
MCPHS University
International Center for
Pharmaceutical Economics and Policy
American Public Health Association, Boston, Nov. 5, 2013
Slide2Presenter Disclosures
(1)The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months:
Lita Araujo
“
No relationships to disclose
”
Slide3Lita Araujo, MSSoeun Kwon, MSMichael Montagne, PhD
Enrique Seoane, PhD
MCPHS University
International Center for Pharmaceutical Economics and Policy
American Public Health Association, Boston, Nov. 5, 2013
Slide4Outline Background
Objectives Data Sources and Methods Results Conclusions Policy Recommendations
Slide5Background
Mechanism of action (MOA) describes a biochemical event indicative of a drug’s pharmacological activityFDA requires MOA on the drug’s label*MOA assists health providers to understand therapeutic applications and possible adverse reactions
* FDA. Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products - Content and Format. Feb 2009
Slide6Objectives
Assessment of the MOA, as described in the product label, for the Anatomical Therapeutic Chemical (ATC) classes of new drugs and biologics approved by the FDA between 1980 and 2012
Slide7Data Sources
Dailymed - National Institute of HealthDrugs@FDA - FDAPhysician's Desk Reference 1980-2013
Slide8Methods
MOA classificationKnown, hypothesized, or unknownThree researchers classified the MOAWHO classification systemAnatomical main group (ATC-1) Therapeutic sub group (ATC-2)Chi-square
test to assess differences in proportions
Slide9Defining Hypothesized MOAs
Equivocating Phrases
Remains to be fully established
Appears to be
Not determined
May be involved
Equivocating Words
Likely
Probably
PostulateSuggest
Slide10Outline Background
Objectives Data Sources and Methods Results Conclusions Policy Recommendations
Slide11Sample
902 new drugs and biologics approved by the FDA during 1980-2012 32 products were excluded870 products included in the study
Slide12MOA Status
Known
579 (67%)
Hypothesized252 (29%)Unknown39(4%)
Slide13MOA Status by Decade
Slide14Chi-square test Orphan drugs vs. Non-orphan drugs
p-value 0.3877Marketed vs. Discontinued drugsP-value 0.0320By decade: 80’ p-value 0.0049
90’ p-value 0.0755
Slide15MOA Status by Anatomical Group ATC-1
Slide16MOA Status by Therapeutic Subgroup ATC-2Musculo-Skeletal System
Therapeutic
Subgroup
n
Known
Hypothesized
Unknown
Antigout Preparations
2
100.00%0.00%0.00%Muscle Relaxants12
91.67%8.33%0.00%Drugs for Treatment of Bone Diseases757.14%42.86%0.00%
Topical Products Joint /Muscular Pain10.00%100.00%0.00%Other Drugs Disorders Musc.-Skel. System20.00%
100.00%
0.00%
Antiinflammatory
and
Antirheumatic
Prods
16
0.00%
81.25%
18.75%
Slide17MOA Status by Therapeutic Subgroup ATC-2Dermatologicals
Therapeutic
Subgroup
nKnownHypothesized
Unknown
Emollients
and
Protectives
1100.00%
0.00%0.00%Preparations Treat. of Wounds and Ulcers1100.00%0.00%0.00%Antipsoriatics
366.67%0.00%33.33%Antibiotics and Chemotherapeutics850.00%12.50%37.50%
Antifungals for Dermatological Use837.50%62.50%0.00%Corticosteroids, Dermatological Preps50.00%
100.00%
0.00%
Anti-Acne Preparations
4
0.00%
75.00%
25.00%
Other Dermatological Preparations
1
0.00%
0.00%
100.00%
Slide18MOA Status by Therapeutic Subgroup ATC-2Nervous System
Therapeutic
Subgroup
nKnown
Hypothesized
Unknown
Other Nervous System Drugs
10
40.00%
50.00%10.00%Analgesics1323.08%
76.92%0.00%Psycholeptics2512.00%48.00%40.00%Anesthetics1010.00%
70.00%20.00%Anti-Parkinson Drugs1010.00%90.00%0.00%Psychoanaleptics263.85%84.62%
11.54%
Antiepileptics
16
0.00%
87.50%
12.50%
Slide19Conclusions
An important number of therapeutic classes have a low proportion of known MOAsMany of the drugs belonging to those classes are used by large number of patientsThe lack of information about MOA could result in safety and efficacy problems
Slide20Policy Recommendations
FDA could develop standardized template for product label with regard to MOAFDA could require compliance with its guidelines and template by manufacturersFDA could encourage manufacturers to continue collecting evidence post-marketing to confirm a drug’s MOA
Slide21What Do We Know About the Mechanism of Action of Drugs in the Different Drug Classes? Assessment of Pharmaceuticals Approved by the FDA between 1980 and 2012
Lita Araujo, MS; Soeun Kwon, MS; Michael Montagne, PhD; Enrique Seoane, PhD
MCPHS University
International Center for
Pharmaceutical Economics and Policy
American Public Health Association, Boston, Nov. 5, 2013