Opportunities for 2008 - Pharmaceutical Technology

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Opportunities for 2008
As FDA implements new drug-safety policies, manufacturers will focus on quality and pricing.


Pharmaceutical Technology
Volume 32, Issue 1

Pushing for comparative-effectiveness analysis

Efforts to determine the appropriate prescribing and pricing of prescription drugs stand to benefit from comparative-effectiveness reviews of medical procedures and products. Better information on what medical treatments work best for certain patients could reduce inappropriate drug use, avoid unnecessary or harmful procedures, and support a more efficient and less costly healthcare system. These possibilities are boosting support for a larger government role in assessing the effectiveness of medical treatment, while health plans and payers also are demanding more evidence that medical products are cost-effective as well as medically safe and effective.

An important issue is what kind of data will support studies comparing the effectiveness of different treatments. Experts anticipate a greater reliance on econometric analysis and observational data, in addition to randomized controlled clinical trials. Such a shift, though, will require clear standards and agreement on analytical approaches for assessing product value.

The challenge for drug and medical product manufacturers is to focus such analysis on how drugs compare to alternative medical and surgical procedures, and to avoid using comparative assessments to control costs or to deny coverage for innovative products. Even if a study indicates that a drug may be less effective for many patients, doctors should have room to prescribe that drug for a smaller patient population that may benefit.

Revising patent policy

Congressional leaders seek to enact sweeping patent-reform legislation that they believe will better protect intellectual property and bring US policy more in line with that of other nations. Software and computer firms support the legislation as likely to reduce their exposure to endless litigation. Biotechnology and pharmaceutical companies, however, fear a serious erosion of patent protections and reduced value for patent awards.

A main issue is a proposed postgrant review system that allows patents to be re-evaluated after they are awarded. High-tech companies believe this strategy could curb patent disputes, but pharmaceutical companies fear that leaving the door open to later challenges will create too much uncertainty about patent value and expose the system to abuse. The proposed bill also aims to prevent "forum shopping" for friendly judges to hear patent-infringement suits by requiring patent holders to file cases locally. Another change makes it harder to challenge a patent based on "inequitable conduct" (i.e., a manufacturer's failure to provide all valid information when filing a patent). This issue often figures into patent disputes between generic and innovator drug companies. Difficulties in reaching a compromise on these issues has delayed legislative action, but key members of Congress are working to finalize the bill this year.

Spurring innovation

To bring new drugs to market more efficiently and with less cost, FDA is collaborating with industry to develop methods for testing and assessing drug safety and efficacy. The agency's Critical Path Initiative encourages public–private partnerships to develop new biomarkers, assess drug-quality issues, and explore new approaches for ensuring product safety. An important project aims to improve methods for assessing liver toxicity in preclinical testing. FDA recently launched a collaboration with Duke University Medical Center to streamline clinical-trial operations through electronic data standards, updated review-board policies, and accreditation programs for clinical investigators and research sites. Other initiatives aim to improve the assessment of medical-product bioequivalence and complex drug-product characterization.

FDA also continues to promote new approaches for ensuring drug quality in the US and abroad. The International Conference on Harmonization is working to finalize guidelines to help manufacturers establish quality systems based on an integrated quality risk-management approach. CDER staffers have been attempting to streamline the manufacturing-supplement submission and review process to greatly reduce this burden on the agency as well as industry. Companies that choose to adopt quality-by-design approaches and good risk-management strategies stand to gain benefits. They could enjoy reduced postmarketing oversight of production changes and less intensive plant inspections as rewards for their efforts.

Curbing conflicts of interest

Some members of Congress and consumer advocates believe it is important to prevent scientists with industry ties from serving on FDA advisory boards. An important FDAAA compromise emphasized the need to reduce conflicts of interest (COIs) among advisors but allowed some waivers so that valuable experts will be able to provide advice when needed. FDA has issued new policies to make COI waiver policies more transparent. The agency is also taking steps to meet Congressional requirements for reducing waivers overall.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
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Source: Pharmaceutical Technology,
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