General Topics

These are the issues that cross cut over all the other ones, such as the importance of patients’ access to accurate information about medical products, improving communications between doctors and patients, decreasing discrimination and disparities in health care, and ensuring appropriate gender, racial, ethnic, and age diversity in clinical trials.

Comments on Draft Guidance for Industry on Internet/Social Media Platforms

The FDA needs to make sure that the information available on the Internet is as accurate and balanced as possible, and should not rely on companies who make the medical products to voluntarily correct flattering or promotional material about the products they are selling. FDA should require companies to correct this information to the greatest extent possible in order to ensure that consumers are not influenced by misinformation that may harm their health.

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”

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

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.

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

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”

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

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.