Published: July 14, 2021
WIT and Leah Quinton, Ph.D., Consulting Expert

The FDA’s Accelerated Approval (AA) program has been around for decades to hasten the process of treating individuals afflicted with severe diseases. So, why has the accelerated FDA approval of a new Alzheimer’s medication gotten the medical community into an uproar? Let’s first look at the drug development process.

From conception to FDA approval, the drug development process typically follows a timeline of 12 years and costs over $1 billion. Since this process is both lengthy and expensive, the FDA created several programs, including the Accelerated Approval (AA) Program in 1992, to serve an unmet need for those who are affected by severe diseases. However, new drugs and biologics are not frequently approved under the AA program. In fact, during a seven-year period (from 2011-2018), only 44 of the 367 approved therapeutics (12%) were approved through the AA pathway.

In the case of Biogen’s Alzheimer’s disease (AD) drug, Aduhelm (Aducanumab), Biogen applied for FDA approval because it saw potential from early clinical trials that would indicate a lessening of a cognitive decline in preclinical or mild AD. The FDA agreed and set it on its path for the accelerated process. News of the broad approval offered optimism and excitement to the public, particularly those affected by Alzheimer’s.

However, should Adulhelm have been broadly approved or approved at all?

The controversy behind the FDA’s approval of the drug stems from insufficient evidence to show that Aduhelm would improve the lives of patients with more advanced disease. When taking the drug, patients risk side effects such as brain swelling or bleeding that usually do not cause noticeable symptoms. Additionally, the cost for treatment ($56,000 a year) and other associated expenses raised concerns that Adulhelm would stoke the hopes of AD sufferers for little to no results at a hefty price.   

Subsequent to the FDA’s initial approval on June 7th, the FDA has since updated its approval label to narrowly limit the drug to patients suffering from mild forms of AD. However, some medical experts still believe that this step falls short of the necessary steps needed to reset expectations further and educate the public on the risks of an alleged hastily approved product.

At WIT, we know that therapeutics are some of the most complicated, most regulated, and most litigated products existing in the market today. Any inconsistencies to the qualification and validation protocols of the product can cause undue harm, lasting damage, and unlimited claims of liability.

To prepare for litigation involving the safety and efficacy of these types of products, it is essential that law firms consult with qualified experts who have first-hand knowledge and experience with the FDA as well as areas relating to downstream drug development, administration, and procurement. 

Below are some examples of experts who can address issues relevant to litigation:

  • Former FDA Officers who are authorities on FDA regulation, compliance, and clinical trial procedures
  • Pharmacologists understand the use, effects, and mechanism of action of drugs.
  • Pharmacists provide counsel to patients to enable them to use medications safely, appropriately, and effectively.
  • Biochemists are familiar with the molecular details that govern biochemical processes in the cell.
  • Physicians are responsible for advocating for their patients, monitoring patient health, and recommending relevant treatment options.
  • Formulations Experts understand the composition of a drug and the mechanism for its delivery in the body during treatment.
  • Drug Label Experts are knowledgeable about the specific language incorporated onto drug labels. They understand the precise intent of the messaging included and the federal requirements that dictate label content. 
  • QA/QC Experts are in charge of ensuring that drugs are produced with the highest and most consistent quality, either during the design and manufacturing of the drug (QA) or by verifying the drug’s quality after its production (QC).
  • Clinical Principle Investigators oversee clinical trials and therefore understand their execution.
  • Biostatisticians and data scientists understand the implementation of statistical methods to draw conclusions from experimental data.
  • Biological engineers and process chemists understand the development of industrial processes, drug production, and clinical manufacturing protocols.
  • Bioethicists weigh the ethical and moral implications of issues relating to biotechnology, medicine, etc.

WIT’s FDA experts have advised on several matters related to drug development. Learn more about our life sciences practice, or contact us to discuss your expert witness needs. Follow us on LinkedIn and Twitter to stay up-to-date on our latest insights.

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