FDA approves new drugs faster than European or Canadian regulators

N Engl J Med2012; doi:10.1056/nejmsa1200223

Regulatory agencies are often accused of being slow to approve new drugs, and the US Food and Drug Administration (FDA) is under pressure to speed up ahead of a five yearly review of its charges. The pressure may be misplaced, say researchers, who report that the FDA approves new drugs significantly faster than both Canadian and European regulators.

In a head to head comparison of review times for new drugs approved between 2000 and 2010, the FDA took a median of 322 days to complete review, compared with 366 days for the European Medicines Agency and 393 days for Health Canada. The researchers analysed 510 approvals of 289 individual drugs, using publicly available data from all three regulators. Nearly two thirds of the drugs approved in both the US and Europe were approved by the FDA first (121/190). More than four fifths of the drugs approved in both the US and Canada were approved by the FDA first (132/154).

The researchers weren’t able to look at review times for unapproved drugs because these records are not accessible to the public. Neither did they examine the quality of regulators’ decisions. Rapid approval must be balanced against public safety, they write. Future studies should compare the regulators for black box warnings, label changes, drug withdrawals, and other possible indicators of hasty and ineffective decision making.

Genetic study challenges causal link between HDL-C and risk of heart attack

Lancet2012; doi:10.1016/S0140-6736(12)60312-2

The association between higher serum concentrations of high density lipoprotein cholesterol (HDL-C) and a lower risk of heart attack is well known. It now seems unlikely that the link is causal, so developing drugs to raise HDL-C concentrations could be fruitless. An international team of researchers has found that adults who are genetically programmed to have high HDL-C have the same risk of heart …