SF Gate highlighted the issue of lengthy regulatory approval processes, labeled by some as bureaucratic slog, and drug safety issues in its recent article “Long, Winding Road to Approval for New Drugs.”
According to the article, biotechnology and pharmaceutical companies face bureaucratic slog to meet U.S. Food and Drug Administration (FDA) standards for safety and efficacy. The article cites Geron Corporation in Menlo Park which has struggled since 1990 to develop a single therapy. Earlier this month, the FDA stopped clinical trials for its only drug, leaving the company still without a drug to sell after 24 years of existence.
Even top pharmaceutical companies have had to wait a long time to gain approval of their first drug. Genentech waited nine years, as did Gilead Sciences. Eighteen years passed before Dendreon Corporation gained regulatory approval, while Isis Pharmaceuticals tops the list at 24 years.
The article provided statistics that shed light on the challenges the biotech industry faces: total costs of developing a single drug runs from $800 million to $1 billion. Time needed to develop one drug may take ten to fifteen years, from discovery to development and finally approval. An investigative compound’s chance of receiving regulatory approval is 1 in 5,000-10,000.
However, the FDA asserts that the lengthy regulatory approval processes ensures that approved drugs are effective and safe. Some experts agree with the FDA’s focus on safety rather than speed, stated the article.
Still, several steps can be taken to lessen bureaucratic slog without compromising safety. One is to streamline and geographically centralize clinical trials to help pharma firms evaluate investigative drugs faster. Another is to trim down broad committees such as ethics boards, which traditionally have multiple committees for multiple test sites. Under the new Partnership to Accelerate Clinical Trials, a single ethics board will monitor multiple test sites for a clinical trial for simplification.
Steps such as those mentioned above can help decrease bureaucratic slog and deliver drugs faster to patients who need them. The full article is available at SF Gate.