DemocracyRules.org - Pledging Issues
Pledging
These are the original issues in this subcategory
  • NURSING SHORTAGE
  • HOSPITAL PREPAREDNESS
  • DRUG SHORTAGES
Winning Issue » DRUG SHORTAGES


Prescription drug shortages have become increasingly common in recent years and outbreaks such as COVID-19 or natural disasters place increasing pressure on our supply chains. Advocates claim that over-reliance on foreign pharmaceutical products is a big reason for these drug shortages, as demonstrated by the impact COVID-19 has had on manufacturers in China and India. However, drug shortages can occur for many reasons, including manufacturing and quality problems, delays and discontinuations. Manufacturers are supposed to provide the FDA with drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages. A drug receives ‘resolved’ status when the FDA determines that the market is covered, based on information from all manufacturers. The market is considered covered when supply is available from at least one manufacturer to cover total market demand.

If a company is the sole supplier of a drug, it is required to notify the FDA six months before it anticipates a shortage of that medication. This important time-period is needed for physicians to acquire substitute medications before a crisis occurs. However, this rule is not enforced and companies do not face any legal consequences if they fail to notify the FDA in time to prevent a drug shortage. Health advocates say these shortages can cause great harm to patients who depend upon these drugs. Besides being forced to use inferior substitutes, there are no studies that predict the effectiveness of a drug that is substituted in the middle of a regimen.

Pending Legislation: H.R.70 - Securing America’s Medicine Cabinet Act of 2021
Sponsor: Rep. Vern Buchanan (FL)
Status: House Subcommittee on Health (Energy and Commerce)
Chair: Rep. Ana Eshoo (CA)



Polling Options

  • I oppose reforming current drug shortage policy, and wish to donate resources to the campaign committee of Speaker Nancy Pelosi (CA).
  • I support the development and approval of advanced pharmaceutical manufacturing technologies and partnering with university research centers to: 1.) Evaluate and approve new drug manufacturing technologies included in an application for drug approval and expedite the development and implementation of such technologies. Designate such a technology as an advanced manufacturing technology if it is likely to prevent or resolve a drug shortage; maintain an adequate supply of critical medications for national emergencies; or promote the adoption of innovative approaches to drug design and manufacturing. 2.) If the FDA validates the technology for a proposed use, then the sponsor may use the validated technology across multiple manufacturing product lines within the same use context without obtaining additional FDA validation. 3.) Designating institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing which demonstrate the ability to provide federal agencies with technical assistance and to train a future workforce in such technologies. And wish to donate resources to the campaign committee of Rep. Ana Eshoo (CA) and/or to an advocate group currently working with this issue.


Winning Option

  • I support the development and approval of advanced pharmaceutical manufacturing technologies and partnering with university research centers to:

    1.) Evaluate and approve new drug manufacturing technologies included in an application for drug approval and expedite the development and implementation of such technologies. Designate such a technology as an advanced manufacturing technology if it is likely to prevent or resolve a drug shortage; maintain an adequate supply of critical medications for national emergencies; or promote the adoption of innovative approaches to drug design and manufacturing.

    2.) If the FDA validates the technology for a proposed use, then the sponsor may use the validated technology across multiple manufacturing product lines within the same use context without obtaining additional FDA validation.

    3.) Designating institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing which demonstrate the ability to provide federal agencies with technical assistance and to train a future workforce in such technologies.

    And wish to donate resources to the campaign committee of Rep. Ana Eshoo (CA) and/or to an advocate group currently working with this issue.
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Pledge Period - Opening Date
July 4, 2022
Pledge Period - Closing Date
July 10, 2022
Trustee Election - Begins
July 11, 2022


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