According to Talk Paper issued by US FDA last month, the highlights of US FDA's accomplishments in 2004 in pharma sector include
" Introduced new initiatives to combat critical health threats such as obesity, counterfeit drugs and medical errors;
" Approved a substantially greater number of products, including an unprecedented number of generic drugs;

Drug Safety - In November, FDA's Acting Commissioner Crawford authorized a series of measures to further strengthen the safety of FDA-approved drugs.

Counterfeit Drugs Task Force Report - This final report focused on securing America's drug supply from counterfeiting. It recommended Radio Frequency Identification Technology (RFIT) to track drug shipments as they move through the domestic supply chain. The FDA report also led many manufacturers to announce their intent to adopt RFIT as well.
http://www.hhs.gov/news/press/2004pres/20040218.html

Critical Path Initiative - This initiative focused on both identifying and finding solutions to the challenge of developing new medical breakthrough technologies. The report called for a vigorous collaborative research effort to create a new generation of medical products.
http://www.fda.gov/bbs/topics/news/2004/NEW01035.html

Current Good Manufacturing Practices (CGMPs) - This initiative is designed to modernize the rules under which FDA regulated products are manufactured. Together with the Critical Path Initiative, the CGMP overhaul is designed to improve and ensure product quality, development of innovative technologies, reduce cost in development and manufacturing of pharmaceuticals.
http://www.fda.gov/bbs/topics/news/2004/NEW01120.html

"Good Tissues Practice" Rule - FDA published the last of three major final rules defining comprehensive protections for patients treated with new technologies involving the use of human cells, tissues, and cellular and tissue based products
http://www.fda.gov/bbs/topics/news/2004/NEW01137.html

New Drugs

Last year FDA's Center for Drug Evaluation and Research (CDER) met or exceeded the performance from the prior year in its drug approval process both for New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) and for New Molecular Entities (NMEs.

Significant new products approved by CDER last year included:
" Apokyn (apomorphine hydrochloride) for the treatment of patients with advanced Parkinson's disease;
" Avastin (bevacizumab) for metastatic cancer of the colon or rectum;
" Clorar (clofarabine) for use in children with lymphoblastic leukemia;
" Pentetate Zinc Trisodium and Pentetate Calcium Trisodium injections for the treatment of internal contamination with plutonium;
" Campral (acamprosate calcium) for the treatment of alcohol dependence;
" Prialt (ziconotide) for the management of chronic pain.
" Kepivance (palifermin) for easing severe oral mucositis in patients undergoing chemotherapy for certain types of cancer;
" Macugen (pegaptanib sodium) for the treatment of macular degeneration; and
" Tarceva (erlotinib) for the treatment of metastatic non small-cell lung cancer.

Generic Drugs

CDER last year approved in record time an unprecedented number of generic drugs, which are up to 70 per cent cheaper than their trade-name counterparts. The Office of Generic Drugs worked with the generic industry to encourage them to submit more complete applications which will facilitate getting generic products onto the market faster. The following table shows a comparison of CY 2004 progress to previous years' performance:

Generic Drug Approvals

Calendar Year	Number Approved	Median Total Approval Time (Months)
1995	222	27
1996	237	23
1997	314	19.3
1998	265	18
1999	242	18.6
2000	305	18.2
2001	307	18.1
2002	384	18.2
2003	364	17
2004	474	15.7

Significant new generics approvals in 2004 included:
" Fluconazole (several dosage forms), an antifungal agent;
" Benazepril hydrochloride, used to treat high blood pressure;
" Ciprofloxacin for antibiotic use, particularly as an anthrax agent;
" Ribavirin, a drug used in combination with interferon alpha 2-A for several indications, including the treatment of chronic hepatitis C; and
" Metformin Hydrochloride (extended release tablets) which is used to treat type II diabetes mellitus.

New Biological Licenses

Significant CBER approvals in 2004 included:
" Rhophylac (Rho(D) Immune Globulin Intravenous) for antepartum and postpartum immunization of Rho(D) negative women;
" Octagam (Immune Globulin Intravenous) for the treatment of several immune deficiencies;
" Three OraSure OraQuick Rapid Tests for the detection of antibodies to HIV-1/2, HIV-1 and HIV- 2; and
" Uni-Gold Recombigen HIV-1, a single-use rapid test for the detection of antibodies to HIV-1 in plasma, serum, and whole blood.


New Devices

The Center for Devices and Radiological Health (CDRH) approved 52 new devices that use new technologies and cleared 3365 devices that used existing technologies. Significant
CDRH approved products included
" Phillips Heart Start Home OTC Defibrillator, the first automatic external defibrillator for use without a prescription;
" Image Checker CT CAD Software System, a new technology to help radiologists analyze computed tomography images of the chest;
" Ex Ablate 200 System, a non-invasive device that uses magnetic resonance image-guided focused ultrasound to destroy non-cancerous uterine fibroids; and
" Paediatric De Bakey VAD, the first miniaturized heart pump approved for children between 5 and 16 years old who need temporary mechanical blood circulation while awaiting a heart transplant.

CDRH also cleared for marketing several important new in-vitro devices, including
" Ampli Chip Cytochrome P450 Genotyping Test, a DNA micro array test that provides unique genetic information to help in selecting a patient's medications and optimizing the dose;
" Neo Gram Amino Acids and Acylcarnitine Tandem Mass Spectrometry Kit, the first blood test cleared for screening infants for certain inherited diseases; and
" Quick ELISA Anthrax-Pa Kit, the first rapid serum antibody test used for detecting antibodies triggered by infection with anthrax.

Other important devices cleared for marketing included
" Cell Search Epithelial Cell Kit/Cell Spotter Analyzer for monitoring the effectiveness of cancer treatment; and
" Ventana Medical Systems' Pathway Anti-c-KIT (9.7) Primary Antibody, the first immuno histochemical marker used to help in treatment selection for patients with a rare gastrointestinal cancer.

First orally-administered, breakthrough therapy for both visceral and cutaneous leishmaniasis

Aeterna Zentaris has received Colombian Food and Drug Agency approval for Impavido (miltefosine), to treat the cutaneous form of leishmaniasis, a severe parasitic skin disease estimated to affect millions of people worldwide. This is the first-ever approval of Impavido for this form of leishmaniasis. The approval also applies for the visceral form (black fever) of leishmaniasis for which Impavido had already received approval by the Indian and German Regulatory Authorities. Impavido thus becomes the first orally-administered, breakthrough therapy for both visceral and cutaneous leishmaniasis.

Israel tightens up clinical research procedures:
Israel's health ministry is to issue new directives for closer scrutiny of studies on patients. The move comes after newspaper publicity about several alleged irregularities in clinical research.

Every hospital will have to appoint a "follow-up body," comprising three members and headed by the institution's internal financial controller or legal adviser. This independent supervisory body will periodically report on its activities to hospital management and to the hospital's Helsinki committee, which is responsible for approving clinical research projects at present.

About 2500 new clinical studies are approved each year by Helsinki committees in Israeli general, geriatric, rehabilitation, and psychiatric hospitals.

Researchers will have to present reports on their work at least twice a year to the hospital's Helsinki committee (compared to once a year or less frequently, under the old system) and if the potential risk to patients in the study is significant they will have to report more often.

--- Compiled and presented as fair use from www by Dr.P. V.Appaji, Executive Director, PHARMEXCIL. appajipv@pharmexcil.com