Policy and Regulation

Biosimilars in the US Cost 2.74 Times More Than in Other Countries

by Veronica Salib

Biosimilars, biologic products similar to brand-name biologics, are praised as a less expensive alternative for patients with chronic diseases requiring biologics. Many providers and healthcare experts...

Unpacking the 340B Drug Pricing Program, Its Impact on the Pharmaceutical Industry

by Veronica Salib

The 340B Drug Pricing Program has evolved significantly since its establishment in 1992. According to an article published by the Commonwealth Fund, the 340B Program is a federal drug pricing program that allows certain hospitals, clinics,...

How Excluding Disabled Populations from Clinical Trials Impacts Care

by Veronica Salib

Using data from ClinicalTrials.gov, researchers collected data on eligibility criteria from approximately 100 clinical research protocols. Of the 97 interventional studies, 14 focused on dementia, 24...

Understanding Differences between Generic, Brand Name, Biosimilars

by Veronica Salib

Every day patients, payers, and providers must navigate the pharmaceutical industry to obtain and deliver treatment. Unfortunately, the industry is full of language and nuances that make this process unnecessarily difficult. When providers...

President Biden Calls for Reform on Marijuana Regulation

by Veronica Salib

For many minority communities, marijuana possession and use can lead to years of incarceration for nonviolent offenses. The Biden administration has recognized that the harsh punishment around...

How Federal and State Laws Have Hindered Access to OUD Treatment

by Veronica Salib

The opioid epidemic has persisted over the past few decades. Exacerbated by the pharmaceutical industry, this epidemic has left many struggling with opioid use disorder (OUD). Effective treatments for...

Medications in the US Are More Widely Available than in Germany

by Veronica Salib

A retrospective cohort study was conducted using data from January 1, 2004, to December 31, 2018. The researchers reviewed information from the FDA and the European Medicines Agency (EMA) to determine...

IVF Provides Additional Resources in Reproductive Health

by Veronica Salib

The overturning of Roe v. Wade in the 2022 Dobbs v. Jackson Women’s Health Organization United State Supreme Court case has brought about a lot of conversation about reproductive rights, including in vitro fertilization (IVF). The...

Federal Judge Rules against Mandated HIV PrEP Coverage

by Veronica Salib

In a recent court ruling, United States District Judge Reed O’Connor declared that mandated HIV PrEP coverage impedes religious freedom. This ruling provides a precedent for employers to refuse...

FDA Approves Bivalent COVID Boosters

by Veronica Salib

As the COVID pandemic progresses and new variants appear, clinicians and public health professionals have been concerned about the level of vaccine protection for new variants and subvariants. To...

WHO Recommends Use of Monoclonal Antibodies in Ebola Treatment

by Veronica Salib

Ebola virus disease (EVD) is a potentially fatal disease caused by infection with ebolavirus. This WHO statement regards EVD caused by the Zaire ebolavirus. Following a review of many randomized...

FDA Considers Dividing Monkeypox Vaccine Doses

by Veronica Salib

Monkeypox was declared a public health emergency by the WHO on Saturday, July 23, 2022. Since the rise of monkeypox rates, public health organizations have urged at-risk populations to seek...

How Pharmaceutical Patents Contribute to Increased Drug Costs

by Veronica Salib

In the United States, drug prices have soared in recent years. The pharmaceutical industry and medicine, in general, have been criticized for these rising drug costs. Beyond the associated financial burden, inflated medication costs also...

Update on FDA Review and Enforcement of Non-Tobacco Nicotine Products

by Veronica Salib

On April 28, 2022, the FDA placed a total ban on all flavored nicotine products in an attempt to reduce the number of nicotine-related diseases and illnesses. Following previous FDA rulings to ban...

Aid Access Discusses Making Abortion Pill Available as Contraception

by Veronica Salib

In an interview with Democracy Now, Rebecca Gomperts, MD, mentioned plans to make mifepristone, the abortion pill, available as a weekly or emergency contraceptive. Gomperts is the founder of Aid...

USPTF Updates Recommendations on Supplements to Prevent Cancer

by Veronica Salib

The Journal of the American Medical Association recently published an updated recommendation from the USTPF on using vitamins and supplements to prevent cardiovascular disease and cancer. The study...

Could the Approval of Albrioza by Health Canada for ALS Impact the FDA Ruling?

by Veronica Salib

This week, Health Canada announced its approval of Albrioza (created by Amylyx Pharmaceuticals) for the treatment of ALS. It has been the only newly approved treatment for ALS since 2018. The drug is...

PhRMA Challenges 340B Drug Pricing Program ADR Rule

by Samantha McGrail

The Pharmaceutical Research and Manufacturers of America (PhRMA) recently filed a complaint stating that the 340B Drug Pricing Program administrative dispute resolution (ADR) rule is “arbitrary...

Trump Issues New Rules to Lower Prescription Drug Pricing

by Samantha McGrail

President Trump recently issued two regulations to lower prescription drug pricing through a slew of new initiatives at aim prescription drug spending in Medicare.  The reforms are the direct...

What is Medicare Part D, What Does It Mean for Pharma?

by Emily Sokol, MPH

Prescription drugs were not covered for Medicare beneficiaries prior to 2006. But the passage of the Medicare Prescription Drug, Improvement, and Modernization Act developed Medicare Part D, a voluntary prescription benefit for Medicare...