New Drug Approvals At Near 20 Year High Despite Industry Claims of Difficulties

A new report suggests that federal drug regulators approved more new drugs in 2015 than in any year over the past 20 years, despite recent complaints by the pharmaceutical industry that regulations have slowed the drug approval process and calls for less stringent requirements before new medications are introduced. 

According to a recent Reuters report, the FDA approved 45 novel drugs in last year, which is the most since 1996, when 53 new drugs were approved.

The report comes as Congress weighs approval of legislation that critics say would force the FDA to approve drugs that have not gone through stringent clinical trials, potentially putting patients at risk and causing Americans to be unwilling test subjects for potentially dangerous treatments.

The increased pace of approvals came due to accelerated review times from reviewers; a trend expected to continue in 2016. However, drug companies complain that the new drugs are not as profitable as they have been in previous years, and they face increased pressure to lower prices on some drugs following a number of high-profile cases that have raised concerns among the public and Congress of price gouging.

Some say that the approval process for new drugs is already too loose. A number of consumer watchdog groups are warning that legislation known as the 21st Century Cures Act would make drug approvals even easier, at the expense of public health.

The bill proposed that instead of requiring randomized blinded clinical trials, the FDA could approve drugs using observational trials only. It also relaxed the need for clinical trials to approve new uses.

Randomized, blinded clinical trials are considered the “gold standard” of medical research, involving a group or groups of patients being given a particular medication while a control group is given a placebo that does nothing. Then those subjects are observed without doctors being aware of who was given the real drug or treatment until data is compiled. Specific endpoints are set, such as a reduction of specific symptoms, and adverse event trends are carefully monitored.

Observational studies involve a control group and an unblinded subject group and draws inferences about the possible effects of treatments. They are considered less reliable for providing definitive evidence of safety, efficacy, or effectiveness.

In 2014, when 41 new drugs were approved, 41% of those drugs were sent through the “orphan” drug program, which is meant to provide fast-track the approval for drugs designed to treat deadly conditions that only impact a limited population. Instead, Johns Hopkins researchers warned in a recent report that the law is being used to approve mainstream blockbuster drugs that are then promoted and prescribed for uses never approved by the FDA.

Many of these drugs move on to become blockbusters, with more than $1 billion in sales. However, the law, originally approved in 1983, was meant to help drug manufacturers introduce medications that would otherwise be unprofitable, granting special patent protections and a faster route to the market, in situations where they would help 200,000 patients or less.

The law grants a drug innovator seven years of market exclusivity before generic competition may be introduced, as well as substantial tax breaks and waivers for millions of dollars of marketing application fees.

According to consumer watchdog group Public Citizen, the proposed 21st Century Cures Act goes even further, allowing drug makers whose blockbuster medications are facing loss of patent protection and generic competition to apply for approval to treat rare diseases, which would grant them six more months of exclusivity.

In February, a study found that the FDA was finding evidence of clinical trial fraud, but not reporting it in most cases.

Supporters of the bill say more flexibility in the FDA approval requirements is necessary to speed up the process of getting vital drugs to patients in a timely manner.