The biotech industry can expect increased regulatory scrutiny and higher production costs for generic drugs in 2014, PCI Synthesis Inc. said in a recent trends analysis.
The FDA continues to expand its oversight of the industry, reports PCI Synthesis, a manufacturer of pharmaceutical ingredients. The recent signing of the Drug Quality and Security Act is an example of the FDA’s expanding regulatory role in the industry, said PCI Synthesis in the Dec. 9 statement.
Producing generic drugs will continue to get more expensive, primarily related to fees imposed by the Generic Drug User Fee Amendments of 2012 (GDUFA). Fees for applications and drug master files (DMFs) could reach $30,000 per DMF, which squeezes smaller companies, according to PCI Synthesis.
Other potential issues in 2014 include drug shortages, a biotech bubble and a lack of skilled industry workers.
More biotech manufacturing could shift back to the U.S. if wage inflation in India and China continues. In addition, any contamination or counterfeiting incidents in the first half could bring more production to the U.S.
For more information, visit www.pcisynthesis.com.