FDA Commissioner shares thoughts on landmark year, drug pricing & more: 6 takeaways

FDA Commissioner Scott Gottlieb, MD, outlined the agency's efforts to reduce drug prices, reflected on 2017's medical innovations and drafted goals for policy in 2018 in a blog post published Jan. 9.

Here are six takeaways from the post.

1. A record year for novel medical innovation. The FDA approved a record 56 novel drugs and biologics in 2017 and recorded 1,027 generic drug approvals, which is the highest annual total of generic approvals in the agency's history. Additionally, in 2017 the agency approved the first gene therapy product in the U.S. and the FDA released new draft guidance that will spur the development of individualized medicines.

2. Efforts on drug pricing. The FDA worked to promote drug competition in 2017 to help make medications more affordable for patients. The agency helped foster generic drug development and paved pathways for quicker generic drug approval.

3. Efforts to combat addiction disorders. In 2017, the FDA proposed to lower nicotine levels in traditional cigarettes to help curb nicotine dependence. Additionally, the FDA established the Opioids Policy Steering Committee, which recommends policies and reevaluates drugs on the market to help confront the opioid epidemic.

4. Efforts to curb antimicrobial resistance. Antibiotic resistance continues to be a major public health concern. In 2017, the FDA set out to improve stewardship and better manage antibiotic usage. The agency launched a website to improve management of antibiotic use and released Guidance for Industry to eliminate the use of medically important antimicrobials in food production.

5. Modernizing regulatory programs. While the advances in medicine will help numerous patients, the FDA is challenged with regulating highly novel areas of science such as gene therapy, cell-based regenerative medicine and digital health. Last year, the FDA advanced its policy framework to make sure beneficial technologies move forward and protect patients from harm.

6. The FDA's priorities in 2018. Dr. Gottlieb highlighted several tasks the FDA will focus on in 2018. The priorities include: advancing policies to spur biosimilar drug production, modernizing policies on over-the-counter drugs and better informing women on health issues and risks.

To read the full blog post, click here.

More articles on supply chain:
Mylan reaffirms $1B share buyback plan
FDA: IV fluid shortage exacerbated by hurricane damage to Puerto Rico is expected to improve
FDA issues recall of J&J's heart device over faulty valve

© Copyright ASC COMMUNICATIONS 2018. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.


Top 40 Articles from the Past 6 Months