Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

An efficient, effective drug development and manufacturing operation is crafted by talented, experienced pharmaceutical scientists and engineers. Synthesizing the recipe for success can be daunting in the current business environment.

	The US unemployment rate, at 4.1%, is at the lowest level in 16 years. More complex molecules demand more sophisticated formulation methods. Advanced technology for pharmaceutical manufacturing will increase the required skill sets of bio/pharma workers. The industry also faces gaps in know-how and expertise as “baby boomer” employees head to retirement.

	These factors suggest a challenge for bio/pharma employers and a positive employment picture for bio/pharma employees seeking to start or advance careers in the bio/pharmaceutical industry. Mix in financial pressures from shareholders and payers, pressure to reduce costs, globalization, and generic-drug competition, however, and the final result may be conflict between employer priorities and employee career paths.

’s annual employment survey (1) shared opinions about the current employment environment, expressed reservations about compensation and workloads, and indicated that better career opportunities were a top priority.

	While nearly 40% of the respondents reported that business increased compared to 2016, fewer respondents felt “more secure” in their positions in 2017 (19.1%) versus 24% in 2016 (2); however, fewer respondents said they felt less secure in 2017 (27.8%) compared with 32.6% in 2016 (

	Opinions about the job market varied. While 44.3% said the job market was moderately competitive, one-quarter said the market for jobs was competitive; there are more qualified candidates than open jobs. The remaining 30% said there are few qualified applicants for open positions and employers must compete for qualified candidates.

More than 480 bio/pharma professionals from around the world responded to the survey, which was fielded in September and October 2017. Respondents primarily were full-time, permanent employees (87.3% of respondents) at innovator bio/pharmaceutical companies (33.8%), generic-drug manufacturing companies (11.6%), contract research and manufacturing organizations (15.8%), and consulting firms (6.4%).

	The represented companies develop or manufacture both small- and large-molecule drugs, vaccines, and cell therapy or regenerative medicines at privately held companies (40.4%), publicly traded companies (40.2%), and non-profit/academic/government groups (14.2%).

	Respondents reported a range of job responsibilities from R&D, to manufacturing, to quality control/assurance. More than 42% work for companies with more than 5000 employees; more than 34% work for companies with fewer than 500 employees.

	Compared with previous years, the respondents reported more experience working in the bio/pharma industry; 24.6% had fewer than 10 years of experience, 28.8% had 10-20 years, 37.4% had 20-35 years of experience, and 9.2% have worked in the industry for more than 35 years. About half of the respondents said they worked outside the bio/pharma industry for up to five years.

	Workloads increase slightly in 2017, with 60.9% reporting increases compared with 59.4% in 2016. More than one-third of the respondents (36.5%) say they worked more hours in 2017 than two years ago, similar to responses in previous years. While 56.3% of the respondents said they were contracted to work approximately 40 hours per week, only 21.6% reported working 40 hours. Nearly one-third (31.4%) said they were contracted for more than 40 hours per week; however, more than 70% of the respondents said they work 40 or more hours per week.

	More than 42% of US-based employees reported two to three weeks of vacation time; 37.1% reported four to six weeks. In comparison, 87% of the European-based respondents reported four or more weeks of paid vacation. Of all respondents, 27.3% reported that they used their full allotment of vacation, personal, and sick time. A similar percentage (22.5%) said they used less than half of the available time off. European-based respondents (70%) were more likely to use at least three-quarters of their paid time off compared to US-based respondents (57.4%).

	Nearly two-thirds of the respondents (62.9%) reported pay increases in 2017, up from 56.5% in 2016, the highest percentage reporting increases since 2014. Satisfaction with salary levels improved compared to the past two years; however, more than half (54%) were dissatisfied with their compensation. More than 35% of the respondents said they were paid at the low end of the salary range for their job function for their expertise and responsibility; 19% said they were paid below market value (

	Benefits are also a key element of employee satisfaction. While more than one-third (36.2%) of the respondents reported an increase in the cost of health insurance, only 8% noted an improvement in coverage. Retirement benefits were unchanged; less than 14% reported an increase in bonuses.

While three-quarters of the respondents have more than 10 years of experience in bio/pharma, 28.9% stayed with the same employer--on average--for three to five years, a decline from 34.1% in 2016. More than 30% of the 2017 respondents said they stayed with an employer for an average of 6-10 years; 35.3% stayed with the same employer for more than 10 years (

	In addition to salary and benefits, employee recognition can play a role in job satisfaction. Most respondents said their work is fully valued by their employer (32.2% strongly agreed; 46.2% agreed). More than three-quarters of respondents said their skills and training are used to the fullest level. Only 56.8% see opportunity for career advancement in their current position; 68.4% reported opportunities for professional advancement at their current companies.

	Compared to previous surveys, fewer respondents to the 2017 survey identified a single factor as motivation to work or a sole reason to change jobs. Challenging projects (33.2%), intellectual stimulation (33.2%), a good work/life balance (26.6%), and a high salary (26.3%) were the top factors respondents cited as “the main reason I come to work.” Work/life balance (33.2%), professional advancement (30.6%), and salary (28.3%) were the top factors for changing jobs. Overall, respondents were tolerant of negative workplace activity; only a small fraction cited single factors that would cause them to quit their jobs; issues with management (14.9%), low pay (12.3%), discrimination (11.5%), and negative attitudes (11.4%) were most frequently cited.

	More than half of the 2017 respondents (54.6%) “agreed somewhat” or “agreed strongly” that they would “like to leave their job, given the opportunity,” down slightly from the past two years. More than one-third said they were “likely to leave my job voluntarily in the coming year,” and 13.5% expected to leave their job involuntarily. In a somewhat concerning result, nearly 23% said they would like to change careers and leave the bio/pharma industry (

	While the desire to change positions is strong, the number of people actually changing jobs is significantly less, but growing. In 2016, 17.2% of respondents reported a voluntary job change; in 2017, that number jumped to 21.7%.

	Confidence levels of those seeking new bio/pharma positions continued to rise in 2017; 25.8% said it would be straightforward to find a comparable new job; 44.4% said it may take a while, but they would be able to find a comparable position. The percentage of less-optimistic job seekers declined slightly, 14.8% said it would be straightforward to find a job, but the new job probably would not be as good as the current position; 15.1% anticipated a difficult search and they would have taken whatever position was available (

Pharmaceutical Technology/Pharmaceutical Technology Europe Employment Survey, Pharmaceutical Technology

2016 Pharmaceutical Technology/Pharmaceutical Technology Europe Employment Survey, Pharmaceutical Technology


	Vol. 41, No. 12
	December 2017
	Page: 16–19

	When referring to this article, please cite it as R. Peters, “Formulating a Recipe for Bio/Pharma Career Success," 

Articles

Attracting and retaining qualified bio/pharma experts demands a mix of recognition, rewards, and opportunities. 

Formulating a Recipe for Bio/Pharma Career Success

 has conducted a survey of the bio/pharma employment environment to assess trends, patterns in salaries and benefits, and employee satisfaction with careers in the industry.

	In addition to the compiled statistics from the 2017 survey (1) reported in this issue (2), the survey gathers participant commentary to open-ended questions on several employment-related topics. As expected, when you ask people for anonymous feedback about their work, the answers range from amusing to angry to thoughtful. Most important, the comments provide honest feedback about a deeply personal topic: the employee’s chosen profession, source of income, and the contributions they make to a cause.

	Recurring themes in the comments included:

		The influence of outsourcing continues to grow, shifting employment opportunities from bio/pharma companies to contract service providers.

		Staff reductions occurred in some functional areas, but increased in others.

		Leadership at the management level is lacking in some organizations.

		The competitiveness of the job market depends on geographic location. In competitive areas, it is very difficult to find and retain qualified talent.

		The small-molecule market segment is contracting; as the biologics segment assumes more of the market share, some pharma veterans are looking for biopharma opportunities.

	The need for adequate staffing, skilled personnel, and training was another common theme. Respondents cited a need for training in leadership and management skills, regulatory science and affairs, technical management, and advanced technology skills.

	Limited availability of qualified workers can have a negative effect on bio/pharma industry growth. Eric Langer noted that employment concerns are one roadblock to continuing growth for the biopharmaceutical industry (3). More than one-half of bioprocessing facilities experienced capacity problems in 2017 due to difficulties in hiring needed operations staff. Outsourcing manufacturing processes due to staff limitations may not be a solution, he noted, as contract manufacturers also face hiring problems.

	In the 2017 survey, less than 5% of the respondents said new hires were “extremely” well trained for their job functions. Nearly 85% of respondents ranked new hires as “adequately trained, but not exceptional,” and more than 14% said the new hires were poorly trained, “I don’t understand how they got their jobs.”

	Respondents also noted the need for training. Approximately 60% of the respondents expressed some dissatisfaction with the lack of training and continuing education at their organization. Nearly one-quarter said the company did not provide adequate training for basic skills; 40% said the company did not provide advanced training for employee professional growth.

	Drug companies need highly skilled, knowledgeable scientists, engineers, technicians, and professionals to develop and manufacture new therapies. Bringing a new drug to market is a long-time, high-investment endeavor. Demands for financial performance, however, have short-term horizons.

	Both employers and employees need to address the training questions.  What are the responsibilities of employees to develop their own workplace skill sets? Will their personal investment in training and education result in career or salary advances? Are bio/pharma companies willing to invest in training? Will that training be sufficient to provide for the skilled workforce needed to get the job done?

, 2017.
	2. R. Peters, “Formulating a Recipe for Bio/Pharma Career Success,” 

, 41 (12) 16-19 (2017).
	3. E. Langer and R. Rader, “Top Trends in Biopharmaceutical Manufacturing, 2017,” 


	Vol. 41, No. 12
	December 2017
	Page: 9

	When referring to this article, please cite it as R. Peters, “Wanted: A Highly Skilled Bio/Pharma Workforce," 

Is pharma up to the task of developing knowledgeable, motivated employees?

Wanted: A Highly Skilled Bio/Pharma Workforce

Editor’s Note: This article was published in 

An efficient, effective drug development and manufacturing operation is crafted by talented, experienced pharmaceutical scientists and engineers. Synthesizing the recipe for success can be daunting, especially in the current uncertain business and regulatory environment.

	More complex molecules demand more sophisticated formulation methods. Advanced technology for pharmaceutical manufacturing will increase the required skill sets of bio/pharma workers. The industry also faces gaps in know-how and expertise as experienced employees retire.

	These factors suggest a challenge for bio/pharma employers and a positive employment picture for bio/pharma employees seeking to start or advance careers in the bio/pharmaceutical industry. Mix in financial pressures from shareholders and payers, pressure to reduce costs, and business and regulatory uncertainties related to Brexit, however, and the final result may be conflicts between employer priorities and employee career paths.

Pharmaceutical Technology/Pharmaceutical Technology Europe

’s annual employment survey (1) shared opinions about the current employment environment, expressed reservations about compensation and workloads, and indicated that better career opportunities were a top priority. While respondents based in Europe generally agreed with their counterparts in the United States and around the world, there were some significant differences.

	More than 45% of the Europe-based respondents reported that business increased in 2017 compared to 2016. Respondents felt “more secure” in their positions in 2017 (21.9%) versus 18.6% in 2016 (2); however, more respondents said they felt less secure in 2017 (26.6%) compared with 25.8% in 2016 (

	Opinions about the job market varied. Nearly one-half of the Europe-based respondents said the job market was moderately competitive, compared with 44.3% for the global audience. Alternately,  21.6% of the Europe-based audience (25% for global audience) said the market for jobs was competitive; there are more qualified candidates than open jobs. The remaining 30% said there are few qualified applicants for open positions and employers must compete for qualified candidates.

More than 480 bio/pharma professionals from around the globe--nearly 20% from Europe--responded to the survey, which was fielded in September and October 2017. Respondents primarily were full-time, permanent employees (87.3% of respondents) at innovator bio/pharmaceutical companies (33.8%), generic-drug manufacturing companies (11.6%), contract research and manufacturing organizations (15.8%), and consulting firms (6.4%).

	The represented companies develop or manufacture both small- and large-molecule drugs, vaccines, and cell therapy or regenerative medicines for privately held companies (40.4%), publicly traded companies (40.2%), and non-profit/academic/government groups (14.2%).

	Respondents reported a range of job responsibilities, from R&D, to manufacturing, to quality control/assurance. Similar to the global responses, more than 47% of the Europe-based responses work for companies with more than 5000 employees; 32% work for companies with fewer than 500 employees.

	Compared with previous years, the Europe-based respondents reported more experience working in the bio/pharma industry; 26.8% had fewer than 10 years of experience, 30.8% had 10-20 years, 35.9% had 20-35 years of experience, and 6.4% have worked in the industry for more than 35 years. About half of the respondents worked outside the bio/pharma industry for up to five years.

	Workloads increased slightly in 2017, with 64.2% reporting increases compared with 56.6% in 2016. Almost one-third of the respondents (32.9%) say they worked more hours in 2017 than two years ago, similar to responses in previous years. While 47.3% of Europe-based respondents (56.3% for US respondents) said they were contracted to work approximately 40 hours per week, only 25.7% (21.6% for US) reported working 40 hours. More than 17% (31.4% for US respondents) said they were contracted for more than 40 hours per week; however, 52.7% of the respondents (more than 70% for US) said they work 40 or more hours per week.

	Vacation and paid time off benefits were more generous in Europe; 87% of the European-based respondents reported four or more weeks of paid vacation, compared with 43.3% for US respondents. Of all respondents, 27.3% reported that they used their full allotment of vacation, personal, and sick time. A similar percentage (22.5%) said they used less than half of the available time off. European-based respondents (70%) were more likely to use at least three-quarters of their paid time off compared to US-based respondents (57.4%).

	Salaries were up globally; in Europe, 58.7% reported a salary increase in 2017, up from 48.7% in 2016. Satisfaction with salary levels improved compared to the past two years; however, more than half (54.7%) were dissatisfied with their compensation. Similar to the global audience responses, 40% of the respondents said they were paid at the low end of the salary range for their job function for their expertise and responsibility; 14.7% said they were paid below market value (

While three-quarters of the respondents have more than 10 years of experience in bio/pharma, 35% stayed with the same employer--on average--for less than five years compared with 24.9% for the global audience. More than one-third of the 2017 respondents said they stayed with an employer for an average of 6-10 years; 31.2% stayed with the same employer for more than 10 years (

	In addition to salary and benefits, employee recognition can play a role in job satisfaction. Similar to the global audience responses, most Europe-based respondents said their work is fully valued by their employer (25.4% strongly agreed; 54.9% agreed). More than 80% of respondents said their skills and training are used to the fullest level. Only 52% see opportunity for career advancement in their current position; 62% reported opportunities for professional advancement at their current companies, slightly lower rates than reported by the US audience.

	Compared with responses from the global audience, Europe-based respondents express strong opinions about single factors that would motivate them to change jobs; professional advancement (38.8%), work/life balance (37.3%), and intellectual challenge (31.3%) were the top factors.

	Similarly, the respondents from Europe were more likely to define single factors as “the main reason I come to work;” intellectual stimulation (40.3%), challenging projects (35.8%), and relationships with colleagues (30%) were the top reasons cited.

	Overall, respondents were tolerant of negative workplace activity; only a small fraction cited factors that would cause them to quit their jobs; issues with management (19.4%), work/life balance (14.9%), a long commute (12.1%), and discrimination (11.9%) were most frequently cited.

	More than half of the 2017 respondents (54.9%) “agreed somewhat” or “agreed strongly” that they would “like to leave their job, given the opportunity,” up slightly from 2016. More than one-third said they were “likely to leave my job voluntarily in the coming year;” only 9.9% expected to leave their job involuntarily. In a somewhat concerning result, nearly 20% said they would like to change careers and leave the bio/pharma industry (

	While the desire to change positions is strong, the number of people actually changing jobs is significantly less, but growing. In 2016, 17.1% of respondents reported a voluntary job change; in 2017, that number jumped to 28.2%.

	Confidence levels of those seeking new bio/pharma positions continued to rise in 2017; 26.9% said it would be straightforward to find a comparable new job; 47.8% said it may take a while, but they would be able to find a comparable position. The percentage of less-optimistic job seekers declined slightly, 13.4% said it would be straightforward to find a job, but the new job probably would not be as good as the current position; 11.9% anticipated a difficult search and they would have taken whatever position was available (

1. 2017 Pharmaceutical Technology/Pharmaceutical Technology Europe Employment Survey, Pharmaceutical Technology

 2016 Pharmaceutical Technology/Pharmaceutical Technology Europe Employment Survey, Pharmaceutical Technology


	Vol. 29, No. 12
	December 2017
	Page: 14–18

	When referring to this article, please cite it as R. Peters, “What are the Ingredients for Bio/Pharma Career Advancement?" 

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

What are the Ingredients for Bio/Pharma Career Advancement?

	CPhI Pharma Awards honor companies and individuals driving the pharma industry forward.

	The winners of the 14th annual 2017 CPhI Pharma Awards were announced on Oct. 24, 2017 at an awards ceremony at the CPhI Worldwide trade show in Frankfurt, Germany. More than 200 entries were received in 2017-twice the number of entries in 2016-and included innovations in products and services for drug formulation, development, manufacturing, drug delivery, packaging, and distribution. In addition, bio/pharma executives and companies were honored for their business, scientific, and social contributions.

	The awards were expanded to nearly 20 categories for 2017 to reflect the increased diversity of attendees at CPhI Worldwide, the organizers report. Separate awards were presented for innovation in formulation and excipients. New categories recognized sustainability practices, export promotion, over-the-counter drugs, patient centricity, and IT, mHealth, and digitalization.

	The entries were reviewed by a panel of independent judges from pharma, industry suppliers, testing labs, and the media, including 

. A list of finalists was announced in September 2017. The winners were revealed during a gala awards ceremony.

	The 2017 CPhI Pharma Award recipients are as follows:

-FlexiQuot: New disruptive technology that revolutionizes sample storage and handling, 1CryoBio

-Development of a new, efficient synthesis of ospemifene, Cambrex

-Modular automated sampling technology (MAST) platform for the biopharma industry, Capsugel/Bend Research (Lonza)

-Modified supercritical anti-solvent (mSAS) technology for accelerated product development, Crystec Ltd.

-Single-use inhaler (DPI) Perlamed-BLISTair, Perlen Packaging

-Opadry QX for tablet film coating, Colorcon

-Waste water treatment plants, Rachana Overseas Inc.

-Orbis’ Optimum Platform: Delivering dispersed dosage forms with functional coatings in a single manufacturing step, Orbis Biosciences

-Biocorp’s line of connected products, Biocorp

-MicroJet Reactor technology with efficient control on particle size and homogeneity of particle size distribution, MJR PharmJet

-Innovation in wart treatment, Pronova Laboratories

-Side actuation device: Innovation in ophthalmic drug-delivery devices, Aero Pump GmbH

-Quality and Regulatory-A Means for Value Creation, Piramal Enterprises

Supply Chain, Logistics, and Distribution

-Industry’s first compliance and digital information platform for the EU Falsified Medicines Directive, TraceLink

-Landfill Free Certification: promoting efficiencies and the conservation of natural resources in a global manufacturing setting, AptarGroup.

	The editors congratulate the awards finalists and winners. Information about the winning technologies will be published in future issues of 


	Vol. 41, No. 11
	November 2017
	Page: 10

	When referring to this article, please cite it as R. Peters, “Awards Recognize Industry Contributions," 

Industry experts were honored for business, scientific, and social contributions.

Awards Recognize Industry Contributions

	Pharmaceutical manufacturing has long played a major role in the economy of Puerto Rico, representing 72.4% of its total exports in 2016, according to the US Bureau of Labor Statistics (1). In 2016, Puerto Rico-based facilities exported $14.5 billion in drug products, 25.5% of the US total and more than the amount of product exported by any US state.

	The US territory, which has struggled for years under a heavy debt burden, took another blow on Sept. 20, 2017 when Hurricane Maria knocked out all electrical power and nearly all phone service for the 3.4 million residents. One week after the storm, the power grid, communications, and transportation systems were in ruins. Food, water, medicines, and other living essentials were in short supply. While government agencies and relief organizations initiated humanitarian efforts, pharma companies with facilities on the island assessed the damage to their facilities and contributed to relief efforts (2).

	AbbVie and Amgen reported minimal damage to facilities, which were running on generators, and were working to restore normal operations. Eli Lilly and Company reported its two manufacturing sites in Puerto Rico had minimal damage, and that operations would not be hindered and there was no supply risk to patients. 

	AstraZeneca reported via an emailed statement that it was receiving updates regarding the status of its plant in Canovanas and its employees, but believed that the facility fared well. Bristol-Myers Squibb said the company was evaluating the situation around its pharmaceutical operations, executing contingency plans to mitigate product supply risk, and working to bring operations back online.

	As of Sept. 27, 2017, FDA identified more than 40 high-priority drugs where short-term disruptions could lead to shortages. The agency is working with at least five companies impacted by the hurricane to prevent critical shortages of medical products in Puerto Rico and across the United States, including coordinating transport of critical drugs from Puerto Rico.

	Previously, tax laws that enabled US drug manufacturers to send profits from the island’s manufacturing facilities to parent companies on the mainland without having to pay federal taxes encouraged companies to establish operations in Puerto Rico. Those incentives expired about 10 years ago, leading to the shutdown of some facilities. Some worry that other facilities damaged by the storm may not reopen (3), hindering the island’s physical and financial recovery.

	FDA Commissioner Scott Gottlieb expressed similar concerns-in addition to worries about drug shortages-in a Sept. 25, 2017 statement (4). “The island is home to a substantial base of manufacturing for critical medical products that supply the entire world. This industrial base is an important source of jobs and economic vitality for the island. It is a key to Puerto Rico’s economic recovery. The manufacturing facilities are also a pivotal source of critical medical products for the entire United States. Helping to bring these resources back in operation is an important goal of ours and of Puerto Rico’s,” the statement read.

	Puerto Rico faces a long, difficult path to recovery. Will Pharma be part of the healing process?

Puerto Rico: Price Movements of Top Exports and Other Highlights

Pharma Gives Update on Puerto Rico Manufacturing Operations

,” Sept. 28, 2017, accessed Oct. 2, 2017.
	3. M.I. Schwartz, 

Pharmaceutical Manufacturing in Puerto Rico after Maria- Where does it go from here?

 FDA Law Blog,  (Sept. 28, 2017) accessed Oct. 2, 2017.
	4. FDA, S

tatement from FDA Commissioner Scott Gottlieb, M.D., on FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base; and to prevent critical shortages of life-saving drugs made in Puerto Rico

	When referring to this article, please cite it as R. Peters, “Pharma’s Role in Puerto Rico’s Future," 

Reeling from financial and tropical storms, Puerto Rico needs stable industry for recovery.

Pharma’s Role in Puerto Rico’s Future

	The summer of 2017 was a busy one for US citizens and companies. It seemed that every week a new crisis or revelation would push equally pressing issues from the front page. The past few months saw an ongoing investigation into alleged Russian meddling in the 2016 election, staff turnover at the White House, violence driven by racial divisions, a nuclear threat from North Korea, and the devastation to lives, homes, businesses and infrastructure in Texas and Louisiana from Hurricane Harvey--to name just a few crucial issues.

	Lawmakers in Washington faced different types of storms as they prepared to return to the Capital from a summer recess. And much of the unsettled atmosphere was of their own creation.

	After much contentious rhetoric--and with limited voter or industry input--Congress failed to agree on a new healthcare plan in July. After years of debate, the lack of agreement and action by lawmakers left many unanswered questions about healthcare, including a battle against a killer that takes tens of thousands of lives per year. 

	A National Academies of Sciences, Engineering, and Medicine (NASEM) report, sponsored by FDA, stated that approximately 90 Americans die every day from overdoses that involve an opioid. As of 2015, at least two million people in the United States were addicted to prescription opioids, and almost 600,000 had an opioid use disorder involving heroin, the report said (1).  

	FDA Commissioner Scott Gottlieb has made the opioid crisis a priority. In June 2017, FDA asked Endo Pharmaceuticals to voluntarily remove Opana ER from the market when postmarketing data indicated a shift in the route of abuse after the drug was reformulated. This action marked the first time the agency requested a company remove an opioid from the market. The drug was withdrawn on July 6, 2017 (2).

	The NASEM report recommended a fundamental shift in the approach to prescribing practice for opioids and improved access to naloxone to combat the effects. The report also suggested that FDA consider public health impacts when making opioid-related regulatory decisions, moving beyond the traditional product-specific approach drug approval decisions, which evaluate data submitted by the drug’s manufacturer and weigh the benefits against the known risks to individual patients.  

	The recommendations offer some good suggestions; however, without guidance or funding from Washington, elected officals, law enforcement, and healthcare professionals in individual states, for now, are on their own to come up with solutions to the epidemic.

	Before leaving for its August recess, Congress overwhelmingly passed the FDA Reauthorization Act (FDARA) approving user fees and FDA program changes needed to maintain the FDA medical product review and approval process. The fees will generate $8-9 billion over five years to support regulatory oversight of prescription drugs and biologics, generic drugs, medical devices, and biosimilars.

	President Trump signed the legislation without fanfare in mid-August. His administration had called for a major increase in industry-paid fees to fully support FDA regulatory programs.

	The reauthorization legislation was the result of two years of negotiations between Congress, FDA, and industry groups. The overwhelming support of the Act demonstrates that Congress can reach consensus. Perhaps they can keep that in mind as they head back to work in September to tackle a full agenda that includes funding for hurricane relief, passage of a spending bill, raising the debt ceiling, tax reform, immigration reform, and the unresolved healthcare issue.

	1. National Academies of Sciences, Engineering, and Medicine, 

Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use

 (Washington, DC, July 13, 2017). 
	2. PharmTech, “

Volume 41, Number 9
	September 2017
	Page: 12

	When referring to this article, please cite it as R. Peters, “The Human Cost of Congressional Stalemates," 

Faced with divisive political and social issues, Congress must find a way to reach consensus.