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Clinical Trial Data Sharing Fact Sheet

PhRMA  |  Fact Sheet

Clinical trials generate incredible amounts of data which are used by the sponsor to answer a specific set of questions; however, these data also have the potential to answer questions beyond the specific trial as well.

The Pharmaceutical Supply Chain: Gross Drug Expenditures Realized by Stakeholder – Study Backgrounder

PhRMA  |  Fact Sheet

Conversations about spending on prescription medicines are often misleading because they do not account for the significant rebates, discounts, and fees paid by brand biopharmaceutical companies or for the distribution costs involved in getting medications to patients. A new study by the Be...

Fact Check Friday: The truth about drug importation and patient safety

PhRMA  |  Blog Post

Meanwhile, other countries have stated they cannot and will not ensure these medicines meet the United States’ rigorous safety and efficacy standards.

Results-Based Contracting: The Need to Reconsider the Anti-Kickback Statute

PhRMA  |  Fact Sheet

Despite the promising benefits of results-based contracts (RBCs) (also called value-based contracts), uptake has been hindered by a range of barriers, including a lack of clarity in the Anti-Kickback Statute (AKS). The AKS is a federal law that prohibits the offering of anything of value with the...

The Dangers of Drug Importation Pocket Card

PhRMA  |  Fact Sheet

Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, from Canada or elsewhere in the world, poses a serious risk to public health. The U.S. Food and Drug Administration (FDA) oversees the most robust drug approval and safety process i...

Fact Check Friday: Negotiations in Medicare Part D

PhRMA  |  Fact Sheet

Check back for more Fact Check Fridays or learn more about Medicare in our Medicare Monday series.

The Value Collaborative

PhRMA  |  From PhRMA

View reports, comment letters, fact sheets and codes and guidelines explaining policy and regulatory changes that can help advance value-driven health care.

Spurring Innovation in Rare Diseases

PhRMA  |  Fact Sheet

Although rare diseases each may individually only impact a relatively small number of patients, defined as less than 200,000 in the United States, their impact on public health is far-reaching. While the median number of patients with each rare disease is less than 10,000, rare diseases affect 30...

The Importance of Risk Evaluation and Mitigation Strategies

PhRMA  |  Fact Sheet

Risk Evaluation Mitigation Strategies (REMS) are a safeguard the U.S. Food and Drug Administration (FDA) may require based on the safety profile of a new medicine or new safety information for a previously approved medicine. The purpose of a REMS is to ensure that the clinical benefits of a medic...

Clinical Trial Data Transparency

PhRMA  |  Fact Sheet

Biopharmaceutical companies are committed to enhancing appropriate transparency of their research in a responsible manner. Clinical trial data transparency has multiple elements, all of which are aimed at improving access to clinical trial information in order to inform medical decision-making, a...

PREA and BPCA: Spurring Pediatric Drug Development

PhRMA  |  Fact Sheet

The Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA), permanently reauthorized in 2012, work together to foster pediatric drug development, creating a balanced approach that generates important safety and efficacy information on use of medicines in children an...

Drug Quality and Security Act and Drug Compounding Backgrounder

PhRMA  |  Fact Sheet

The Drug Quality and Security Act (DQSA) was signed into law in 2013, following the tragic national outbreak of fungal meningitis which killed 64 people and infected more than 750 others, impacting patients in at least 23 states. The Centers for Disease Control and Prevention traced the outbreak ...

Fact Check Friday: The Truth About Industry's Role in R&D

PhRMA  |  Fact Sheet

In fact, the biopharmaceutical sector spends more on R&D than the entire National Institutes of Health operating budget with PhRMA member companies investing $51.2 billion in 2014, and over half a trillion dollars since 2000.

Fact Check Friday: The truth about IPAB

PhRMA  |  Blog Post

FACT: IPAB’s broad powers are transferred to the Secretary of Health and Human Services (HHS) if a board is not appointed or confirmed and the statute is triggered.

340B Drug Discount Program Pocket Card

PhRMA  |  Fact Sheet

As part of the program, manufacturers provide steep, mandatory discounts on medicines to certain types of clinics and hospitals as a condition of their medicines being covered by Medicaid.

340B Spotlight: Myth vs. Fact

PhRMA  |  Graphic

Congress created the 340B program in 1992 to help health care safety-net facilities that serve a large proportion of needy or uninsured patients have access to discounted prescription medicines. Unfortunately, over the years a lot of myths have been perpetuated about how the program works and who...

America’s Biopharmaceutical Companies R&D Investments at an All-Time High

PhRMA  |  Fact Sheet

R&D investment by America’s innovative biopharmaceutical companies reached record levels in 2016, according to the latest PhRMA annual member survey....

Rheumatoid Arthritis Treatments Continue to Demonstrate Increased Value through Additional Research

PhRMA  |  Fact Sheet

This fact sheet includes new data that reveals broader benefits than anticipated at the time of FDA approval for RA treatments.

Fact Check Friday: Communications with Payers

PhRMA  |  Fact Sheet

In this Fact Check Friday, the myth is all about communication with payers.

Biosimilars 101

PhRMA  |  Fact Sheet

In this Biosimilars 101 Fact Sheet, we take a deep dive into biosimilars and biologics.

Fact Check Friday: The Truth about IPR and Biopharmaceutical Patents

PhRMA  |  Blog Post

The proof is in the fact that 88% of prescriptions filled in the U.S. are for generics – up from just 19% before the law’s enactment – and the use of generics generated nearly $1.5 trillion in savings to the U.S. health care system from 2004-2013.

The Reality of Prescription Drug Spending in Medicaid

PhRMA  |  Fact Sheet

The share of spending growth attributable to prescription me...

Fact Check Friday: Medicaid spending on prescription medicines

PhRMA  |  Blog Post

Read more on the reality of prescription drug spending in Medicaid here and sign-up for updates to get the latest Fact Check Friday myths and facts.

Legislative and Regulatory History of the Evolution of 340B Program

PhRMA  |  Fact Sheet

The 340B program was created by Congress in 1992 to help vulnerable or uninsured patients access prescription medicines at safety net facilities. Learn the history of the evolution of this program....

Survey Finds Variability in MS Treatment Preferences Among Individual Patients, and Among Stakeholder Groups.

PhRMA  |  Fact Sheet

Real Endpoints, LLC (RE), a data analytics firm focusing on assessing and quantifying pharmaceutical value, has just completed an extensive literature review and survey to tease out how different stakeholder groups assess the value of current multiple sclerosis (MS) therapies....

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