Fw: Med Watch Form Update ... Deadline coming .. April 11th

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----- Original Message ----- From: ilena rose

ilena@...

Sent: Sunday, March 09, 2003 4:05 PM

Subject: Med Watch Form Update ... Deadline coming .. April 11th

We have just a little while to get this information to the FDA ...

Rogene commented on it on the newsgroup:

~~~~~~~~~~~~~~~

From: Rogene (saxony02@...)Subject: Re: Urgent ... Med Watch Form Update ... Deadline coming

View this article onlyNewsgroups: alt.support.breast-implantDate: 2003-03-08 07:25:17 PST Interesting stipulation . . . .

"Hospitals are not required by Federal law or regulation to submit

adverse event reports, product problems, or medication errors

associated with medications, biological products or special

nutritional products."

Same thing for individual health providers . . .

I'm speechless!

Rogene~~~~~~~~~~~~~~~~~~~~~~~Then I read this on Inamed's online brochure ...Making an Informed Decision

www.inamed.com/pdf/us_aesthetics/M713D_Informed_Decision.pdf

I found something quite troubling on Inamed/McGhan’s current “Making an Informed Decision” brochure.

In the area where they discuss the unfortunately, non-mandatory MedWatch reports for breast implant complications, the emphasis is not on self-reporting to the FDA, but getting a “medical professional” to report “your” adverse affect.

I have personally spoken to Plastic Surgeon’s who have never reported a complication to the FDA, nor the numbers of their various surgeries to the Plastic Surgeon’s Union, now called ASPS.

How would it benefit a PS to do all the paperwork necessary to report a complication to the FDA?

Or a Rheumatologist to report a disease he doesn’t believe is related to his patient’s implants?

Adverse reports have been found to be VERY under-reported ...

Anyone who has never filed one before ... or who has had additional surgery, infections, diseases, etc. please update your report.

Ilena Rosenthal

http://www.BreastImplantAwareness.org

Here's the info from the FDA with April 11th deadline

EXCERPT: DATES: Submit written or electronic comments on thecollection ofinformation by April 11, 2003.Federal Register Notices:Agency Information Collection Activities; Proposed Collection;MedWatch: TheFDA Medical Products Reporting Program; Comment Requesthttp://www.fda.gov/OHRMS/DOCKETS/98fr/03-3174.htm[Federal Register: February 10, 2003 (Volume 68, Number 27)][Notices] [Page 6752-6754]From the Federal Register Online via GPO Access [wais.access.gpo.gov][DOCID:fr10fe03-90] & n bsp; [[Page 6752]]-----------------------------------------------------------------------DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration[Docket No. 03N-0016]Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment RequestAGENCY: Food and Drug Administration, HHS.ACTION: Notice.-----------------------------------------------------------------------SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of informat ionandto allow 60 days for public comment in response to the notice. This notice solicits comments on the ``MedWatch: The FDA Medical Products Reporting Program'' forms (Form FDA 3500--voluntary version and Form FDA 3500A--mandatory version). These forms are currently used toreportto the agency about adverse events, product problems, and medication errors that occur with FDA regulated products, including drugs, biologicals, medical devices, and special nutritional products.DATES: Submit written or electronic comments on the collection of information by April 11, 2003.ADDRESSES: Submit electronic comments on the collection of informationtohttp://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html'>http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html & log=linklog & to=http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.Submit written comments on the collection of information to theDocketsManagement Branch (HFA-305), Food and Drug Administration, 5630FishersLane, rm. 1061, Rockville, MD 20852. All comments should be identifiedwith the docket number found in brackets in the heading of this document. Submit written requests for single copies of the revised MedWatch reporting forms, Form FDA 3500 (voluntary) and Form FDA 3500A(mandatory), to MedWatch: The FDA Safety Information and Adverse EventReporting Program (HFD-410), Food and Drug Administration, 5600FishersLane, rm. 15B-18, Rockville, MD 20857. Send one self-addressedadhesivelabel to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION for electronic access to the MedWatch reporting forms.FOR FURTHER INFORMATION CONTACT: L. , Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.SUPPLEMENTARY INFORMATION:I. Background Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3© and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.Section 3506©(2)(A) of the PRA (44 U.S.C. 3506©(2)(A)) requires Federal agencies to provide a 60-day notice in th e Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection ofinformationis necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptionsused; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden ofthecollection of information on responden ts, including through the use ofautomated collection techniques, when appropriate, and other forms of information technology.MedWatch: The FDA Medical Products Reporting Program, Forms FDA 3500 and FDA 3500A (OMB Control Number 0910-0291)--Extension Under sections 505, 512, 513, 515, and 903 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355, 360b, 360c, 360e, and393); and section 351 of the Public Health Service Act (42 U.S.C.262),FDA has the responsibility to ensure the safety and effectiveness of drugs, biologics, and devices. Under section 502(a) of the act (21 U.S.C. 352(a)), a drug or device is misbranded if its labeling isfalseor misleading. Under section 502(f)(1) of the act it is misbranded if it fails to bear adequate warnings, and under section 502(j), it is misbranded if it is dangerous to health when used as directed in its labeling. ; Under section 4 of the Dietary Supplement Health and Education Actof 1994 (the DSHEA) (21 U.S.C. 341), section 402 of the act (21 U.S.C.342) is amended so that FDA must bear the burden of proof to show a dietary supplement is unsafe. To carry out its responsibilities, the agency needs to be informedwhenever an adverse event, product problem or medication error occurs.Only if FDA is provided with such information, will the agency be ableto evaluate the risk, if any, associated with the product, and take whatever action is necessary to reduce or eliminate the public's exposure to the risk through regulatory action ranging from labeling changes to the rare product withdrawal. To ensure the marketing ofsafeand effective products, certain adverse events must be reported. Requirements regarding mandatory reporting of adverse events orproductproblems have been codified in parts 310, 314, 600, and 803 (21 CFR 310, 314, 600, and 803), specifically Sec. Sec. 310.305, 314.80, 314.98, 600.80, 803.30, 803.50, 803.53, and 803.56. To implement these provisions for reporting of adverse events, product problems and/or medication error with medications, devices, biologics, and special nutritional products, as well as any other products that are regulated by FDA, two very similar forms are used, Form FDA 3500 is used for voluntary (i.e., not mandated by law or regulation) reporting of adverse events, product problems, and medication errors by health professionals and the public. Form FDA 3500A is used for mandatory reporting (i.e., required by law or regulation). Respondents to this collection of information are health professionals, hospitals and other user-facilities (e.g., nursing homes, etc.), consumers, manufacturers of biological and drugproducts,medical devices, and i mporters.II. Use of the Voluntary Version (FDA Form 3500) The voluntary version of the form is used to submit all adverse event, product problems, and medication error reports not mandated by Federal law or regulation. Individual health professionals are not required by law or regulation to submit adverse event, product problem, or medication error reports to the agency or the manufacturer, with the exception ofcertain adverse reactions following immunization with vaccines as mandated by the National Childhood[[Page 6753]]Vaccine Injury Act (NCVIA) of 1986. Those mandatory reports are submitted by physicians to the joint FDA/Centers for Disease Control and Prevention (CDC) Vaccines Adverse Event Reporting System (VAERS)onthe VAERS-1 form (seehttp://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html'>http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html & log=linklog & to=http://www.vaers.orgfor pdf version) rather thanthe FDA 3500 or 3500A forms. Hospitals are not required by Federal law or regulation to submit adverse event reports, product problems, or medication errors associated with medications, biological products or specialnutritionalproducts. However, hospitals and other user facilities are required byFederal law to report medical device related deaths and serious injuries. Manufacturers of dietary supplements do not have to prove safetyorefficacy of their products prior to marketing, nor do they have mandatory requirements for reporting adverse reactions to FDA.However,the DSHEA puts the onus on FDA to prove that a particular product is unsafe. The agency is dependent on the voluntary reporting by health professionals and consumers of suspected adverse events associatedwiththe use of dietary supplements.III. Use of the Mandatory Version (FDA Form 3500A)A. Drug and Biologic Products In sections 505(j) and 704 (21 U.S.C. 374) of the act, Congresshasrequired that important safety information relating to all human prescription drug products be made available to FDA so that it cantakeappropriate action to protect the public health when necessary.Section702 of the act (21 U.S.C. 372) authorizes investigational powers toFDAfor enforcement of the act. These statutory requirements regarding mandatory reporting have been codified by FDA under parts 310 and 314 (drugs) and 600 (biolo gics). Parts 310, 314, and 600 mandate the useofthe FDA Form 3500A form for reporting to FDA on adverse events that occur with drug and biologics. [Note: Most pharmaceutical manufacturers already use a one-page modified version of the 3500A form where Section G from the back oftheform is substituted for Section D on the front of the form.]B. Medical Device Products Section 519 of the act (21 U.S.C. 360i) requires manufacturers andimporters of devices intended for human use to establish and maintain records, make reports, and provide information as the Secretary of Health and Human Services may by regulation reasonably require to assure that such devices are not adulterated or misbranded and to otherwise assure its safety and effectiveness. Furthermore, the Safe Medical Devices Act of 1990 (SMDA), signed into law on November 28, 1990, amends section 519 of the a ct. The amendment requires that user facilities such as hospitals, nursing homes, ambulatory surgical facilities and outpatient treatment facilities report deaths relatedtomedical devices to FDA and to the manufacturer, if known. Serious illnesses and injuries are to be reported to the manufacturer or toFDAif the manufacturer is not known. These statutory requirements regarding mandatory reporting have been codified by FDA under part803.Part 803 mandates the use of the FDA Form 3500A for reporting to FDAonmedical devices.C. Other Products Used in Medical Therapy There are no mandatory requirements for the reporting of adverse events or product problems with products such as dietary supplements. FDA estimates the burden for completing the forms for this collection of information as follows: & nb sp; Table 1.--Estimated Annual ReportingBurden\1\---------------------------------------------------------------------------------------------------------------- Annual No. of Frequency Total Annual Hours per Total FDA Center (21 CFR Section) Respondents per [chyph]Responses [chyph]Response Hours Response----------------------------------------------------------------------------------------------------------------Center for Biologics Evaluation and Research/ ........... ......... ................ .. ............. ......Center for Drug Evaluation and Research Form 3500 20,074 1 20,074 0.5 10,037 Form 3500A (Sec. Sec. 310.305, 314.80, 600 463.86 278,315 1.0 278,31 314.98, 600.80) & n bsp; 5Center for Devices and Radiological Health ........... ......... ................ ............... ...... Form 3500 3,252 1 3,252 ; 0.5 1,626 Form 3500A (Sec. 803) 1,935 33 63,623 1.0 63,623Center for Food Safety and Applied Nutrition ........... ......... ................ ............... ...... Form 3500 895 & n bsp; 1 895 0.5 448 Form 3500A (no mandatory requirements) 0 0 0 1.0 0----------------------------------------------------------------------------------------------------------------Total Hours & nbsp; 354,04 9< BR> Form 3500 12,111 Form 3500A & n bsp; 341,93 8----------------------------------------------------------------------------------------------------------------\1\ There are no capital costs or operating and maintenance costsassociated with this collection of information. NOTE: FDA Form 3500 is for voluntary reporting; FDA Form 3500A is for mandatory reporting. The figures shown in Table 1 of this document are based on actual fiscal year 2002 reports and respondents for each Center and type of report.IV. Electronic Access Persons with access to the Internet may obtain the MedWatch reporting forms, Form FDA 3500 (voluntary) and Form FDA 3500A (mandatory) athttp://frwebgate.access.gpo.gov/cgi-bin/l eaving.cgi?from=leavingFR.html & log=linklog & to=http://www.fda.gov/medwatch/getforms.htmor by calling1-800-FDA-1088 and leaving your name and mailing address. Copies oftheMedWatch reporting forms, Form FDA 3500 (voluntary) and Form FDA 3500A(mandatory) are available for public examination athttp://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html'>http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html & log=linklog & to=http://www.fda.gov/ohrms/dockets/dockets/dockets.htmor in the Dockets[[Page 6754]]Management Branch (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. Dated: February 4, 2003.Margaret M. Dotzel,Assistant Commissioner for Policy.[FR Doc. 03-3174 Filed 2-7-03; 8:45 am]BILLING CODE 4160-01-S

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