Opportunity or challenge? Favorable policies promote the increase of drug approval(1)

Global:

The U.S. Food and Drug Administration (FDA) is taking advantage of policy groundwork laid in past years to speed drug approvals. There have been 34 novel drugs approved this year for cancers and rare genetic diseases by September 29, 2017, with the approval speed almost double of that of last year. So far, at least 9 decisions came more than 20 days ahead of the FDA’s scheduled action date.

Comparison of novel drugs approved by FDA in recent decade (picture source: bloomberg)

There are two reasons for such fast drug approval:

• Policy stimulus

Americans spend more than people of any other country on prescription drugs. Trump has vigorously promoted medical reform and promised to reduce medicine prices of citizens since taking power, therefore, the U.S. government hopes to reduce drug price through accelerating drug approval.

Top 10 spenders per capita on drugs in 2014 (data source: Organization for Economic Cooperation and Development)

• New acts providing legal guarantee for fast drug approval

There are mainly four methods of FDA to accelerate novel drug approval, separately being fast track, breakthrough therapy, accelerated approval and priority review. The fast track aims at novel drugs to treat serious diseases and fill the current gaps in clinical medication; the breakthrough therapy aims at novel drugs which may demonstrate substantial improvement over available therapy; the accelerated approval aims at novel drugs that fill the current gaps in clinical medication and approved based on a surrogate endpoint.

According to provisions of the U.S. Prescription Drug User Fee Act, the FDA shall complete review of 90% varieties in 6 months for innovative drugs that receive priority review, and in 10 months for innovative drugs that receive normal review.

The GDUFA Generic Drug User Fee Act passed by the U.S. government in 2012 establishes a mechanism to reduce the review time, such as for the breakthrough therapeutic regimens, and expands the use of accelerated approval; it provides a faster review process for drugs, with the aim of providing safe and effective generic drugs to patients who urgently need them, thereby providing patients with substantial medical improvement. The act is authorized once every 5 years, and the President of the U.S. Trump approved the reauthorization of the act on August 18 this year.

Is this an opportunity or challenge to pharmaceutical enterprises?

1. Safe and innovative drugs can timely enter market

FDA stresses that the changes to increase speed aren’t at the expense of safety, therefore, accelerating the novel drug review may promote drugs of some leading pharmaceutical enterprises with strong R&D strength or innovative drug enterprises to timely enter market, and be conductive to purifying the entire drug approval environment, guiding and encouraging pharmaceutical enterprises to conduct drug innovative R&D and increasing the overall R&D motive power of pharmaceutical enterprises.

2. Future price competition is a challenge that cannot be avoided

AstraZeneca’s olaparib was approved on August 17 to be used for patients with BRCA positive and negative ovarian cancer, which can be on a par with the competitive treatment of Tesla Inc. and bring price competition to this cancer field. Such competition will hand the initiative to patients instead of pharmaceutical enterprises.

In addition, FDA has recently approved the enasidenib of Celgene and Agios Pharmaceuticals’ cancer drug for adults with acute myeloid leukemia (AML), wherein, the enasidenib approved on August 1 was approved nearly one month earlier than the expected date. Surprisingly, those drugs were not conducted placebo trial or conducted difference comparison with current standard therapies, making people think that what FDA’s accelerated approval considers may only be handing drugs to patients ASAP.

The possibility of novel drug approval has been increased, and the purposes will be more extensive. The marketing of a large number of generic drugs will cause the drug price to reduce, however, the drug R&D cost of pharmaceutical companies is high, which is a factor that investors have to consider, therefore, this may not be good news for pharmaceutical enterprises.

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