PRINTER'S NO. 339
No. 64 Session of 2003
INTRODUCED BY YUDICHAK, KELLER, DeWEESE, D. EVANS, SOLOBAY,
BELARDI, BISHOP, CORRIGAN, COY, FREEMAN, GRUCELA, HENNESSEY,
MANN, MELIO, SCRIMENTI, THOMAS, WALKO, YOUNGBLOOD, JOSEPHS,
BELFANTI, CAPPELLI, COSTA, CRUZ, GOODMAN, HASAY, HORSEY,
LAUGHLIN, McCALL, READSHAW, JAMES, STABACK, TIGUE, WATSON,
HERSHEY, MYERS AND PALLONE, FEBRUARY 18, 2003
REFERRED TO COMMITTEE ON INTERGOVERNMENTAL AFFAIRS,
FEBRUARY 18, 2003
A RESOLUTION
1 Memorializing the Food and Drug Administration to review the top
2 50 prescription drugs as determined by direct-to-consumer
3 spending each year to determine if they can be switched to
4 over-the-counter status.
5 WHEREAS, The Food and Drug Administration (FDA) has the
6 authority to conduct evaluations each year of various
7 prescription drugs to determine whether the drugs may be
8 switched to over-the-counter (OTC) status; and
9 WHEREAS, The findings of these evaluations describe the
10 safety and effectiveness of each drug, its benefit-to-risk ratio
11 and whether clear and understandable labeling can be written for
12 self-medication without intervention of a health care
13 professional; and
14 WHEREAS, Drugs that are limited to prescription use under a
15 New Drug Application can be exempted from that limitation if the
16 FDA determines the prescription requirements to be unnecessary
1 for the protection of public health; and
2 WHEREAS, The cost of a prescription drug is growing at a
3 double-digit rate, making it increasingly difficult to provide
4 affordable broad-based prescription benefits to low-income and
5 middle-income individuals; and
6 WHEREAS, According to the FDA:
7 Drugs found appropriate for over-the-counter sales have
8 an increasingly vital role in the United States health
9 care system by providing consumers easy access to certain
10 drugs that can be used safely for conditions that
11 consumers can self-treat without the help of a health
12 care practitioner. Consumers have access to more than
13 100,000 OTC drug products encompassing more than 800
14 active ingredients and covering more than 100 therapeutic
15 categories or classes;
16 and
17 WHEREAS, The availability of OTC drugs saves approximately
18 $20 billion each year, taking into account prescription costs,
19 doctor visits, lost time from work, insurance costs and travel;
20 therefore be it
21 RESOLVED, That the House of Representatives of the
22 Commonwealth of Pennsylvania memorialize the FDA to review the
23 top 50 prescription drugs as determined by direct-to-consumer
24 spending each year to determine if they can be granted OTC
25 status; and be it further
26 RESOLVED, That copies of this resolution be transmitted to
27 the FDA and to each member of Congress from Pennsylvania.
A14L82BIL/20030H0064R0339 - 2 -