General Topics – Page 2 – Patient, Consumer, and Public Health Coalition

Comments from Coalition On the Department of Health and Human Services (HHS) Proposed Rule “Voluntary 2015 Edition Electronic Health Record Certification Criteria: Interoperability Updates and Regulatory Improvements”

April 28, 2014 April 26, 2022

We strongly encourage ONC to include automatic identification and data capture (AIDC) such as bar codes in its 2015 Edition and not wait until the 2017 Edition. Using an AIDC system saves physicians time and is more accurate (it avoids human error such as transposing of numbers). Adding UDI information to EHRs would improve patient care in several ways.

Letter to Congresswoman DeLauro Thanking Her for Her Dedication to Patients and Consumers

February 6, 2014 April 26, 2022

We are writing to thank you for your dedication to patients and consumers through your work to strengthen safeguards for all medical products sold in the United States. Your continued efforts through the years, including your recent letter to the FDA Commissioner, is needed now more than ever to help preserve the public health mission of the FDA.

Members of the Patient, Consumer, and Public Health Coalition strongly support FDA’s ban on the imports of Ranbaxy medical products

September 26, 2013 April 26, 2022

We strongly support the FDA’s ban on importing drugs manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The company’s facility is not complying with current good manufacturing practices (cGMP), which are the main regulatory safeguard to ensure drug manufacturing quality.

Comments Re: FDA’s Recent HELP Committee testimony on pharmacy compounding

November 30, 2012 April 26, 2022

We generally support the VALID Act because it will give the FDA the clear regulatory authority it needs to prevent tragedies such as the contaminated steroid injections that have resulted in hundreds of cases of fungal meningitis and more than 30 deaths. However, Congress should absolutely clarify the legal status of section 503A, which should be revised to delete the unconstitutional advertising provision.

Comments Re: “Questions for Stakeholders Regarding Appropriate Regulation of Pharmacy Compounding”

November 2, 2012 April 26, 2022

We welcome the opportunity to provide our views regarding pharmacy compounding. Stronger regulations are clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths. Current laws and regulations regarding compounding pharmacies have resulted in giant loopholes that allow medical products that are neither safe nor effective to be sold throughout the country, putting patients’ lives at risk.

Comments to the Centers for Medicare and Medicaid Services on Transparency Reports and Reporting of Physician Ownership or Investment Interests

February 17, 2012 April 26, 2022

We agree with the Institute of Medicine and the Medicare Payment Advisory Commission (MedPAC) that “enhanced disclosure and transparency [is needed] to discourage the inappropriate use of financial incentives and lessen the risk of such incentives interfering with medical judgment and patient care.” While we strongly support the proposed rule overall, there are several major loopholes that need to be fixed.