Regulatory Beat: Biologics Oversight Challenges Federal Regulators - Efforts to ensure purity and safety of biotech therapies and vaccines have required innovative thinking for more than a century - B


Regulatory Beat: Biologics Oversight Challenges Federal Regulators
Efforts to ensure purity and safety of biotech therapies and vaccines have required innovative thinking for more than a century

BioPharm International
Volume 19, Issue 8

The modern generic drug industry also emerged with Congressional approval of the 1984 Drug Price Competition and Patent Term Restoration Act, or Hatch-Waxman Act. The bill allowed FDA to approve identical versions of brand-name drugs based on innovator preclinical and clinical testing. In return, brand-name companies gained up to five years additional patent protection to compensate for time spent waiting for FDA to approve a new drug. Because this legislation applies only to drugs, a major legal battle to authorize "similar" versions of biotech therapies has erupted as significant biologics are beginning to lose patent protection.


All of these new programs greatly increased FDA's responsibilities and made it difficult for staffers to review applications and inspect manufacturing facilities in a timely manner. The resulting delays generated support for the Prescription Drug User Fee Act of 1992, which required pharmaceutical and biotech companies to pay fees to support a more efficient FDA review process for NDAs and BLAs.

A global initiative to accelerate drug development by harmonizing product testing standards also was launched at this time.

In 1992, FDA joined regulators and manufacturers from Europe and Japan to establish the International Conference on Harmonization, which produced numerous guidelines for assessing drug quality and for conducting preclinical animal tests and clinical studies.

In reauthorizing the user fee program in 1997 (PDUFA II), Congress enacted the FDA Modernization Act (FDAMA) that revised many agency practices. A key section of this law provides six months of added exclusivity on a drug if the manufacturer conducts additional studies to add pediatric information to the product's label.


Efforts to support biomedical innovation and streamline FDA regulatory processes have become even more visible in recent years. In the wake of 9/11, Congress approved the Project BioShield Act of 2004, which encourages development of drugs and vaccines to prevent or treat bioterrorist threats. FDA launched a major project in 2002 to update the regulation of good manufacturing practices for drugs and biologics that advocates a more risk-based approach for inspecting manufacturing facilities and ensuring product quality.

Another key initiative champions new approaches and new tools to encourage pharmaceutical innovation. FDA's Critical Path report of 2004 urges additional agency collaboration with industry to spur R&D, and a subsequent Opportunities List describes a range of research and regulatory initiatives with potential to lead to more biomedical discovery.

At the same time, drug safety has emerged as a major public concern. Evidence linking Cox-2 inhibitor painkillers to cardiovascular events spurred a major outcry in 2004 that lax FDA policies were exposing patients to unsafe drugs. Manufacturers pulled a number of products off the market, and FDA launched several initiatives to make drug safety oversight more open and effective, with more changes still to come.

Today, FDA has some 10,000 staffers and a $2 billion annual budget. Agency leaders strive to promote patient access to needed therapies as well as to keep unsafe products off the market. Globalization has transformed how FDA monitors regulated products; user fees have altered the agency's relationship with pharmaceutical and biotech manufacturers; and new technologies continually change how FDA conducts business, developments that will continue in FDA's next hundred years.

Jill Wechsler is BioPharm International's Washington editor, 7715 Rocton Avenue, Chevy Chase, MD 20815, 301.656.4634

blog comments powered by Disqus



GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
Author Guidelines
Source: BioPharm International,
Click here