Discussion about this post

User's avatar
First Amendment's avatar

Excellent article which fills in many of the blanks i.e. Henry Waxman. Many have been asking how the NCVIA came about and how it was rationalized. The Congressional Record makes for insightful reading into Congress.

This is critical: I've been asking if HHS can require doctors to explain the package insert to patients. According to the clause at the end of this section, which states, "make health practitioners and the public aware of potential adverse reactions and contraindications," I would think so.

From 10/14/1986, p. 37051, Program Responsibilities, Sec. 2102(a), https://www.congress.gov/99/crecb/1986/10/14/GPO-CRECB-1986-pt21-3-2.pdf: (6) Distribution and Use of Vaccines: "the Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction to the Centers for Disease Control and assistance to States, localities, and health practitioners in the distribution and use of vaccines, including efforts to encourage public acceptance of immunizations and to make health practitioners and the public aware of potential adverse reactions and contraindications to vaccines." Somehow, "safe and effective" doesn't sound like they are making the public or health practitioners aware of AE's. I would think they are, therefore, in violation of this law. What do you think?

In addition, rules were suspended and Waxman's amendment was approved via voice vote: "Agreed to the Waxman amendment in the nature of a substitute that provides for drug export amendments, National Commission to Prevent Infant Mortality, childhood vaccine injury compensation, health care quality improvement, State comprehensive mental health services plans, geriatric training, health planning, health maintenance organization amendments, and Alzheimer's disease research." Page 33143 https://www.congress.gov/bound-congressional-record/1986/10/18

No posts

Ready for more?