The Importance of Modernizing the Drug Discovery and Development Process

Brought to You by Black Health Matters and PhRMA         

For every prescription medication you take, biopharmaceutical companies go through years of highly regulated and complex testing before they can be made available for patients. It is a long and expensive proposition. On average it costs $2.6 billion to identify, research, and develop a new medicine for regulatory approval before it ever becomes available for your doctor to prescribe. It can also take 10 to 15 years to bring a drug to the marketplace and 12 percent of medicines that begin clinical trials are actually approved by the FDA.

Why Does It Take So Long?
Developing innovative medicines is a long and complex process involving years of research, development and clinical trials. These trials are fundamental to ensuring the safety and efficacy of medicines before they ever reach patients. Biopharmaceutical research companies are working closely with the U.S. Food and Drug Administration on efforts to speed medicines to patients faster while ensuring safety isn’t sacrificed. The FDA and biopharmaceutical companies continually monitor prescription medicines to ensure they remain safe for patients and to research their use in additional patient populations or disease indications. 

African Americans Often Left Out of the Equation
Regulatory approvals for new medicines are based on carefully designed clinical trials. Ideally, participation in clinical trials would be representative of the patient populations impacted by the disease under study. Unfortunately, a lack of awareness about clinical trials, misperceptions about the clinical trial process, and the fact that most physicians don’t talk to their patients about clinical research means that fewer than 10 percent of Americans participate in clinical trials.¹ Lack of participation is even greater amongst minority groups. This failure to achieve meaningful diversity limits information about drug response and measures of safety and efficacy in historically under-represented and under-studied populations, including women, ethnic and racial minorities, children and the elderly. Multi-stakeholder initiatives are required to provide solutions to these challenges.

What Can You Do?
Talk to your doctor about clinical trials that might be appropriate for you and volunteer to participate in trials. There are many reasons African Americans don’t participate, including distrust of the system because of the history of clinical research. The best way to overcome this barrier is through education.

• Be your own best advocate. Do your homework. Sites like clinicaltrials.gov can link you to drug trials for your particular illness and information on what qualifies you for the trial.
• Armed with your research, you can talk to your doctor about getting into clinical drug trials. 
• Participate in clinical research when you can. The only way drug development and medical treatment that addresses the needs of African Americans can come to the marketplace is through participation. And pay attention to what the trial is offering you. Participation does not necessarily mean you will get the drug the trial is testing, you might receive the best standard of care instead.
• Enroll in NIH’s All of Us clinical research program, a national initiative designed to speed up health research and medical breakthroughs, to enable individual prevention and treatment. They are actively recruiting African American participation. 

Innovation Fighting COVID-19
Since the emergence of the novel coronavirus, there has been a robust collaborative effort within the public and private sector to develop potential treatments and vaccines for the virus. As of April 2020, there are over 300 treatments and vaccines in clinical trials, with nearly 50 of those occurring in the U.S.² The decades-long investments biopharmaceutical companies have made in new technologies, research and treatments have prepared the industry to act swiftly to respond to the public health crisis.

What About Testing and Treatment?
In addition to working collaboratively on the development of a vaccine, there have been robust efforts on developing new testing and treatments for coronavirus. Recently, PhRMA member companies adopted core principles that include a commitment to rapidly screen their vast global libraries of medicines to identify potential treatments, and donate millions of doses of existing medicines that have shown potential as treatments to COVID-19. In addition, biopharmaceutical manufacturers across the country are coordinating with government and diagnostic partners to increase COVID-19 testing in communities. 

What About the Costs of Testing, Vaccines and Treatment?
Rightfully so, there has been a lot of talk about how much it will cost the consumer for diagnostic testing, an eventual vaccine, and treatments of COVID-19. The good news is that in March two critical pieces of legislation were passed by Congress and signed by the president which will provide relief to those receiving testing and a future vaccine. The first was the Families First Coronavirus Response Act³, which mandated that health plans, Medicare, and Medicaid provide coverage for coronavirus testing without cost sharing. 

The second was the CARES Act, which addressed the coverage of a future vaccine. For individuals within Medicaid, with Medicare Part B or Medicare Advantage plans, coverage for a vaccine will be offered without cost sharing. For those with a commercial plan, coverage for a vaccine will occur within 15 days of the U.S. Prevention Services Taskforce A or B recommendation, or a recommendation from the Advisory Committee on Immunization Practices. 

Regarding treatment, Medicaid, traditional Medicare, and Medicare Advantage plans will provide coverage of treatments for individuals who become ill with coronavirus. In addition, the nation’s leading health plans⁴ are making numerous affordability options available to their members, including financial assistance and waived cost sharing for in-patient treatment. They’ve also expanded access to telehealth services for those with other chronic conditions. 

—Andrea King Collier

^{1 https://www.researchamerica.org/sites/default/files/July2017ClinicalResearchSurveyPressReleaseDeck_0.pdf
2 Analysis of publicly available databases such as cilnicaltrials.gov, AdisInsights and the World Health Organization’s International Clinical Trials Registry Platform (WHO ICTRP) as of April 8, 2020. 
3 https://www.congress.gov/bill/116th-congress/house-bill/6201/text
4 https://www.ahip.org/health-insurance-providers-respond-to-coronavirus-covid-19/}