Highlighted below are five issues that are poised to present challenges to pharmaceutical companies in 2015, as outlined by the Wall Street Journal.
1. The backlog of U.S. Food and Drug Administration approval for generic drugs. Roughly 3,500 applications for generic drugs await processing from the FDA for interim actions or complete approvals, meaning the few generics on the market are expensive.
2. Robust mergers and acquisitions activity. M&A activity in 2014 nearly doubled last year’s and is expected to continue an upward trend into the first half of 2015.
3. Medication costs continue to rise. The cost of drugs, be they brand-name or generic, is rising. Although pharmaceutical companies may view the trend as an opportunity to increase revenue, payers are expected to begin pushing back.
4. The Indian government’s approach to patents is still up in the air. Although the Obama administration has encouraged the Indian government to do more to protect intellectual property and patents, consumer advocates argue doing so may restrict access to medicines for Indians and for poor countries that are supplied by India’s generic-drug makers.
5. Pay-to-delay deals may undergo antitrust scrutiny. Pay-to-delay deals allow brand-name drug makers and generic rivals engaged in patent litigation to reach a settlement but doing so opens the companies up to antitrust scrutiny by the U.S. Supreme Court. A federal appeals court will be deciding a case in the near future regarding such deals.
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