FDA Articles

The new drug review offices at the Food and Drug Administration are "drowning in meetings," according to FDA officials, and the volume may grow even faster if the agency adopts recommendations from a new report on factors that slow drug development and application approval. FDA is taking steps to make sponsor meetings more productive and more uniform among its many drug review divisions. The agency also is looking for more resources to support the time and effort involved in preparing for and conducting meetings, a topic that is on the table in negotiating renewal of the Prescription Drug User Fee Act (PDUFA) next year.

Growing volume

It’s been seven years since the FDA made its initial attempt to bring drug submissions into the information age. At one point, many in Pharma and Biopharma thought they were facing a computer crisis of nearly Y2K proportions, but subsequent clarifications and the August 2003 Guidance have assuaged many fears about the extent of compliance. Since the initial 21 CFR Part 11 ruling, the FDA has adopted a risk-based approach to compliance, which has definitely had an impact on how Part 11 has been interpreted. The Guidance is an effort by the FDA to narrow interpretations and return to the fundamentals (the predicate rules, that is) for generating electronic records and electronic signatures.

Jill Wechsler
FDA has to decide by the end of the year whether to implement a rule to track a drug's pathway from manufacturer to final dispenser, even if it means starting with an outmoded, paper-based pedigree system. The policy aims to thwart drug counterfeiting, which is on the rise around the world. This poses a serious threat to public health, particularly when injectable drugs are involved. While FDA has delayed action, states and major retailers are responding by implementing their own drug pedigree requirements. Manufacturers are testing authentication and tracking systems. So far, most solutions appear costly, but may be valuable in modernizing inventory and distribution systems and avoiding legal and regulatory problems.

PUSH FOR RFID

The Food and Drug Administration's Prescription Drug User Fee program (PDUFA) has to be reauthorized by Oct. 1, 2007, and all the interested parties are fine-tuning their wish lists for "improvements." Although some consumer advocates and their Congres-sional allies blast user fees for extending industry control over the drug approval process, FDA officials, pharma companies, and patient disease groups applaud the program's success in ending "drug lag" and speeding new drugs and biotech therapies to market.

FDA held a meeting in November to open the PDUFA 4 debate. Acting Commissioner Andrew von Eschenbach termed PDUFA reauthorization "critical" to FDA's ability to make "biomedical innovation a reality." Deputy Commissioner Janet Woodcock described how user fees have been expanded twice since 1992 to support a broad range of FDA activities, from early discovery to post-market surveillance, including improvements in agency information systems.

MORE FOR SAFETY

In trying to bring pharmaceutical manufacturing regulation into the twenty-first century, the US Food and Drug Administration is doing more than talk. The agency is changing fundamental concepts of regulation and backing those changes up with initiatives to encourage process developers to keep improving their production systems—even after approval.

he controversy surrounding the appointment
of Lester Crawford to head the Food
and Drug Administration reflects the importance
of the post and the difficulty of finding
anyone with the scientific and political skills to
fill it. Crawford’s nomination was put on hold for
several months as various legislators sought to
pressure FDA to take action on pet issues. Some
senators first wanted the agency to decide whether
to approve an over-the-counter version of the
emergency contraceptive pill, “Plan B,” while
others pressed for FDA support of broader drug
importing.

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Pharmaceutical & Medical Packaging News
February 1999

Jill Weschler
Applied Clinical Trials, Apr 1, 2004

Pharmaceutical Executive, Mar 1, 2002

New guidance documents and rule changes are part of FDA’s attempt to speed new cancer treatments to market.

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