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Statements on Introduced Bills and Joint Resolutions

Location: Washington, DC


By Mr. DEWINE (for himself and Mrs. CLINTON):

S. 226. A bill to amend the Public Health Service Act to improve immunization rates by increasing the supply of vaccines; to the Committee on Health, Education, Labor, and Pensions.

Mr. DeWINE. Mr. President, I rise today, along with my colleague from New York, Senator CLINTON, to introduce the Improved Vaccine Supply Act--a bill that would help ensure that our Nation's public health system has an adequate vaccine supply.

We all know that vaccinations are critical in our efforts to keep our population, particularly children and the elderly, healthy. They are key to protecting the elderly from influenza during flu season and protecting children from contracting polio or the mumps. Vaccinations, inoculations, immunizations--whatever you want to call them--also help lessen the threat of bacterial or viral infections and potential disease outbreaks.

Currently, it is recommended that children receive 12 routine vaccinations against preventable diseases. These vaccinations are given in a series of shots and booster shots by the age of two, with an additional four doses later in life. This ends up being about 16 to 20 doses of vaccines for children.

Any shortage of vaccines is not acceptable, and we should do all we can to prevent any future shortage. As a Senator, and more importantly, as a parent of eight and grandparent of eight, I believe that nothing is more important than the health and safety of our children. While we are not currently experiencing a shortage, we know that the vaccine market is unstable and unpredictable. According to the Centers for Disease Control's National Immunization Program, there were several reasons for the shortages in past years. The CDC concluded and posted on its website that the ``reasons for these shortages were multi-factorial and included companies leaving the vaccine market, manufacturing or production problems, and insufficient stockpiles.''

The CDC did as good a job as it could, considering the vaccine shortages our Nation has faced in past years. The agency's website has posted information about shortages and released revised vaccine schedules to keep our public informed and knowledgeable about vaccination shortages. But, even with the strong efforts of the CDC, we need to work toward preventing a future vaccine shortage. We need a more permanent solution. The bill I am introducing will go a long way toward doing just that.

The bill we are introducing today--the Improved Vaccine Supply Act--would help bring some stability to our fragile vaccine supply. Unlike drug manufacturers, vaccine manufacturers do not have to give notice when they stop making a vaccine, whether the vaccine is withdrawn from the market intentionally or because the manufacturer is simply unable to continue making the vaccine. Essentially, these manufacturers leave the marketplace with no notice and no warning. Most doctors and hospitals--and more importantly parents and older adults--often have no idea that a vaccine is in short supply until they line up for a flu shot or go to the doctor for their child's immunizations.

Our bill would change this. It would require any manufacturer of a vaccine to give a one-year notice of discontinuance. By giving notice, the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) would be better able to ensure an adequate vaccine supply for our Nation's population. Additionally, our bill would require all drug and vaccine manufacturers to give notice when they withdraw from the market. This change would ensure that we have a better sense of who is making vaccines and drugs and would allow the CDC and FDA to monitor the manufacturer's production and release of vaccines.

Let me explain why this is important. Vaccines, or biological products, are difficult to develop and manufacture. They are more complex than drugs. Because of this, it takes longer for a biological product to reach the market. For example, a pharmaceutical company that manufactured tetanus vaccine stopped producing it, leaving only one company to produce tetanus vaccine for the entire country. The remaining company increased production to accommodate all of the needs of the United States. Despite this, it still required about 11 months for the vaccine to be ready for release. In other words, it took 11 months for the company to ramp-up production to meet demand. Our bill would create a notification mechanism to capture those drugs and vaccines leaving the market so we can avoid future vaccine and drug shortages.

Our bill also would require the Secretary, acting through the CDC, to develop a plan for the purchase, storage, and rotation of a supply of vaccines sufficient to provide routinely recommended vaccinations for a six-month period for children and adults. Essentially, it would create a framework for the CDC to develop a national vaccine stockpile to ensure that childhood vaccine shortages simply do not occur.

Our children need and deserve timely vaccinations. When childhood vaccinations are in short supply or are unavailable, they do without, living unprotected against disease. That should never happen. The bill we are introducing today is another step toward ensuring that children get the vaccines they need and that they get them at the right time. I urge my colleagues to join me in support of this important public health legislation.

I ask unanimous consent that the text the bill be printed in the RECORD.

There being no objection, the bill was ordered to be printed in the RECORD, as follows:

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