[Congressional Record Volume 144, Number 28 (Monday, March 16, 1998)]
[Senate]
[Pages S1995-S1996]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DODD:
  S. 1767. A bill to amend the Federal Food, Drug and Cosmetic Act to 
require notification of recalls of drugs and devices, and for other 
purposes; to the Committee on Labor and Human Resources.


            the drug and device recall reporting act of 1998

  Mr. DODD. Mr. President, I rise today to introduce a critical measure 
that has the potential to save many lives--``Matthew's Law.'' This bill 
is named after a very lucky third-grader from Bridgeport, Connecticut, 
whose life was endangered by the failure of his pharmacy to notify his 
family that an unsafe medical device had been pulled from the market.
  It is both unfortunate and remarkable that no Federal legislation 
currently exists that requires notification of consumers when unsafe 
drugs or devices are recalled. State laws also fail to guarantee 
consumers the right to know of recalls. Although 18 States recommend 
that pharmacists notify their patients of recalls, as part of 
professional standards of care, only one State (Vermont) explicitly 
requires that patients be contacted.
  This bill will amend the Federal Food, Drug, and Cosmetic Act to 
impose the commonsense requirement that when pharmacies are notified of 
a class I or II recall of a drug or device dispensed by prescription, 
they must notify their patients that the product has been pulled from 
the market.
  Class I recalls include those drugs and devices that could reasonably 
cause serious adverse effects on health or death. Class II recalls 
include drugs and devices that may cause temporary or medically 
reversible adverse effects on health.
  For over the counter drugs and devices, the bill requires that a 
notice regarding the recall be displayed in the pharmacy. Pharmacies 
that fail to comply will be subjected to fines of up to $10,000.
  Matthew McGarry, for whom this bill is named, has a life-threatening 
allergy to peanuts. In case he should accidentally eat one, he carries 
a device with him that injects a drug to counteract an allergic 
reaction, called an ``EPI-E-Z'' pen.
  When it was found that a few of the devices in one batch were leaking 
the life saving drug, all pharmacies were notified that the product was 
being recalled. And almost all pharmacies, acting in the best interest 
of their patients, in turn notified consumers. The McGarry's pharmacy, 
however, did not contact its patients.
  Thanks to the vigilance of his school's nurse, Betty Patterson, 
Matthew escaped unharmed--the defective device was replaced.
  Under current law, consumers have the right to be notified their 
automobiles are defective or when the toys that their children play 
with are found to be unsafe. It is only logical that we should have the 
same peace of mind when it comes to products like drugs and medical 
devices that directly affect our health.
  Most pharmacists do the right thing. Most pharmacists contact their 
customers when a drug or device is recalled. However, it takes just one 
incident, like that experienced by the McGarry family, to point out a 
dangerous loophole in the law.
  With Matthew's law, we will close that loophole and protect all 
American families from the McGarry's frightening experience.
  Mr. President, I ask unanimous consent that a copy of the bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1767

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Drug and Device Recall 
     Reporting Act of 1998''.

     SEC. 2. RECALLS.

       Subchapter E of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding 
     at the end the following:

     ``SEC. 564. NOTIFICATION OF RECALLS.

       ``(a) Notification to Customers.--A pharmacy that receives 
     notice from a recalling firm regarding a Class I or Class II 
     recall of a drug or device shall provide notification about 
     the recall to customers that received the drug or device as 
     follows:
       ``(1) In the case of a drug or device dispensed by the 
     pharmacy to customers on the prescription of a licensed 
     practitioner, by providing, at a minimum, written 
     notification to each of the customers.
       ``(2) In the case of another drug or device, by public 
     display in the pharmacy of a notice regarding the recall.
       ``(b) Civil Penalty.--Any pharmacy that violates subsection 
     (a) shall be liable to the United States for a civil penalty 
     in an

[[Page S1996]]

     amount not to exceed $10,000 for each such violation.
       ``(c) Definitions.--In this section:
       ``(1) Class i or class ii.--The term `Class I' or `Class 
     II' refers to the corresponding designation given recalls in 
     subpart A of part 7 of title 21, Code of Federal Regulations, 
     or a successor regulation.
       ``(2) Recall.--The term `recall' means--
       ``(A) a recall, as defined in subpart A of part 7 of title 
     21, Code of Federal Regulations, or a successor regulation; 
     and
       ``(B) a recall under section 518(e).
       ``(3) Recalling firm.--The term `recalling firm' means--
       ``(A) a recalling firm, as defined in subpart A of part 7 
     of title 21, Code of Federal Regulations, or a successor 
     regulation; and
       ``(B) a person subject to an order issued under section 
     518(e)(1).''.

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