Department of Pharmacy Systems, Outcomes and Policy, College of Pharmacy, University of Illinois at Chicago, Chicago, 833 S. Wood Street, Rm 287 (M/C 871), Chicago, IL, 60612, USA.
Ther Innov Regul Sci. 2020 Mar;54(2):424-430. doi: 10.1007/s43441-019-00072-8. Epub 2020 Jan 6.
The 2006 FDA's Unapproved Drug Initiative (UDI) aimed to improve safety and public health by decreasing the availability of drug products that never obtained FDA approval (unapproved drug products) in the market and incentivizing manufacturers to emphasize that these products must obtain FDA approval. The objective of this study was to measure changes in the prices, sales, and quantities sold of drug products approved under the FDA-UDI.
Drug products that obtained voluntary approval under FDA-UDI from 2006 to 2015 were identified and trends in prices, sales, and units sold were analyzed using the IQVIA National Sales Perspective database.
Eleven drug products were included in the final analysis. Relative to baseline levels 2 years before approval, a steep increase in price and sales was observed 2 years postapproval for all except 2 of the drug categories-with median percent change of 245% (range: -37% to 9618%) for price and 238% (range: -4% to 6707%) for sales. Substantial variance was observed in the changes in units sold.
A marked increase was seen in postapproval prices and sales for the vast majority of drug products approved in the FDA-UDI with mixed results in changes in units sold. In addition to increased information on safety, the policy's impact on postapproval drug prices and associated effects on units sold should be considered in assessing the policy, especially when substantial price increases and decreases in units sold may negatively impact health.
2006 年 FDA 的未批准药品倡议（UDI）旨在通过减少市场上从未获得 FDA 批准的药品（未批准药品）的供应，以及激励制造商强调这些产品必须获得 FDA 批准，来提高安全性和公共卫生。本研究的目的是衡量在 FDA-UDI 下批准的药品的价格、销售和销售量的变化。
确定了在 2006 年至 2015 年期间根据 FDA-UDI 自愿获得批准的药品，并使用 IQVIA 国家销售透视数据库分析价格、销售和销售量的趋势。
最终分析包括 11 种药品。除了 2 种药品类别外，所有药品类别在获得批准后的 2 年内，与批准前 2 年的基线水平相比，价格和销售均出现大幅上涨，价格中位数变化百分比为 245%（范围：-37%至 9618%），销售中位数变化百分比为 238%（范围：-4%至 6707%）。销售单位的变化存在很大差异。
在 FDA-UDI 中批准的绝大多数药品的批准后价格和销售均出现显著增长，而销售单位的变化结果喜忧参半。除了增加安全性信息外，在评估该政策时，还应考虑该政策对批准后药品价格的影响及其对销售单位的相关影响，尤其是当价格大幅上涨和销售单位大幅下降可能对健康产生负面影响时。
