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Aligning Expectations: Can the US FDA and Industry Meet in the Middle?

This article was originally published in SRA

Executive Summary

The life sciences industry is poised to revolutionise healthcare over the next decade through the development of more targeted and effective treatments. To realise the potential of this healthcare revolution, pharmaceutical and medical device companies and regulators should make a greater effort to collaborate toward the goal of bringing high-demand, innovative and safe products to market, writes Michael Mentesana.

A recent report by consultants PricewaterhouseCoopers on the working relationship between the life sciences industry and the US Food and Drug Administration, Improving America’s Health V1, reveals that while the industry and the FDA have taken steps to improve their relationship during the past few years, some challenges remain. Alongside the PwC report, a companion consumer survey shows that respondents have mixed feelings about the FDA and little knowledge of the industry’s challenges or the cost of drug development.

The tension that exists and complicates the industry-FDA relationship is due in part to the conflicting expectations of all stakeholders involved. While consumers ask for safer, more effective drugs and devices and expect quick access to innovative treatments, the industry wants faster and more efficient product approval in return for its significant investment of research, time and money. Added to the equation is private and government payer demand for better quality, lower-cost healthcare that demonstrates economic and clinical value. Balancing these wants, needs and expectations creates challenges for the industry and the FDA, but also offers some real opportunities.

The first priority for the FDA is to fulfill its legal duty to protect the public health by ensuring the safety and effectiveness of drugs, vaccines and devices. The agency has traditionally looked at whether the benefits of a new treatment outweigh the risks for most of the population. This task has grown increasingly complex: the science of medicine has rapidly advanced toward more specialised treatment; the industry has expanded globally; and healthcare reform has put new mandates on the FDA and industry.

Most agree that the regulatory process needs to evolve at the same rate as science and technology, which have given us greater insight into the role genetic differences play in individual responses to medical treatments. In recent years, the industry has turned its focus on developing more personalised drugs and devices targeting specific patient groups, such as those with a particular genetic makeup or those with a rare disease. Accordingly, the FDA has implemented programmes to speed approval of innovative products that address unmet needs. Yet faster time to market, for the most part, has not been realised.

The Improving America’s Health V survey, whose purpose was to provide data for the FDA and industry to inform their interactions and decisions, found that companies feel their relationship with the FDA has improved steadily during the past few years. Frustration remains, however, with the pace and complexity of the regulatory review process.

User fees

For example, questions related to user fees. These questions were drafted as the FDA sought public comment on the reauthorisation of the Prescription Drug User Fee Act and the Medical Device User Fee Amendments, both scheduled for 2012. The survey revealed misaligned industry and FDA perceptions of the success of user fees. Only 24% of industry respondents agreed that the FDA is using the fees as intended, and half indicated a desire for greater transparency into the fees’ purpose and use. Similarly, only 32% agreed that user fees accelerate product reviews, and 46% disagreed (see Figure 1).

Industry positive on some issues, negative on others

Other survey findings were mixed. On the positive side, only 16% of companies indicated they had done nothing to improve their relationship with the FDA. Some 38% of respondents indicated they had seen improvement in the overall relationship during the past two years, while 40% were neutral. Only 12% said that their relationship had not improved.

Almost 80% of industry respondents said that FDA guidance documents had improved their understanding of the agency’s expectations during the past two years. More than two thirds (68%) of respondents indicated they had done better in incorporating FDA feedback into the development process (see Figure 2).

Regarding areas that could be improved, more than 60% of industry respondents expressed frustration that the FDA had changed its position during a review; 40% indicated that inadequate review resources at the agency led to product denial (Figure 3).

A majority (58%) of industry respondents agreed that politics has too much influence on the regulatory approval process. This perception could be due to leadership changes at the agency or to Congressional authority over the FDA’s budget and user fee reauthorisation. The response could also reflect calls from Congress for greater regulatory oversight following publicity over high-profile product recalls in recent years.

The industry also perceived shortcomings with the FDA in keeping up with rapidly advancing technology. Only 8% of drug and device makers indicated that the agency was doing enough to advance personalised medicine. More than half (56%) of respondents who were familiar with the FDA’s Critical Path Initiative (aimed at bringing innovative, high-priority therapies to market quickly) thought that the FDA currently lacked the capability to implement the initiative. Surprisingly, not all companies responding to the survey were familiar with the initiative.

The Improving America’s Health V survey revealed a need for more open communication and collaboration between the industry and the FDA. For example, results showed that the industry does not always take advantage of pre-submission and end-of-phase meetings, and that the FDA does not consistently encourage attendance.

The survey was conducted against a backdrop of monumental change in the industry – a time that saw the passage of the Patient Protection and Affordable Care Act, new FDA leadership and growing pressure from the public and politicians for more vigilant drug and device safety measures.

Consumer attitudes ambivalent

Most people in America don’t realise the time, cost and complexity of the drug and device development process, according to the companion survey that PwC undertook. PwC conducted the survey of 1,000 adult US consumers to gauge public perceptions of the FDA and how they compare with the industry’s views – partly because consumers’ preferences and expectations increasingly influence healthcare policy.

Two-thirds of the consumer survey respondents agreed that the US has the highest standards in the world for drug safety and effectiveness. Yet, more than half (56%) said they would be willing to use drugs and devices approved outside the US before the treatments receive FDA approval.

More than one-third (35%) said they had lost confidence in the FDA during the past two years owing to widespread negative publicity about product failures and safety concerns. This is another area where a balancing act is needed between industry and the FDA and the education of the population.

Not surprisingly, the consumer survey also indicated that respondents hold contradictory views about the industry. A majority (63%) believed that manufacturers don’t fully disclose safety concerns or issues. Nonetheless, consumers continue to use the industry’s products, with 93% of the survey respondents indicating they were confident that medicines or medical devices approved for use in the US are safe. Indeed, 80% said they had not experienced a negative reaction or side effect to any prescription or over-the-counter medicine or medical device.

The consumer survey, conducted online and completed in October 2010, also revealed that respondents lack a basic understanding of how the industry works. For example, although bringing a new prescription drug from lab to market can take up to 12 years, 54% of respondents believed it took only five years or less to develop and test a new drug before it could be sold in the US. Only 12% thought that the process took more than 10 years.

While most of the consumer survey respondents (68%) understood that the FDA is partially taxpayer funded, only 36% knew that the industry helps fund FDA activities. Some 70% of respondents disagreed with the notion that makers of drugs and medical devices should be able to pay an extra fee to the federal government to get their products approved faster.

The FDA stands at an inflection point of understanding how it needs to change to modernise the drug and device review and approval process. Both sides – the regulator and the industry – could do more to improve the working relationship and move regulatory science forward. Rapid advancement in personalised medicine, industry convergence and the strong movement toward outcomes-based reimbursement have created urgency for the industry and the FDA to work together to transform the regulatory approval process.

Improving America's Health V survey

The Improving America’s Health V survey continues a series of surveys conducted by PricewaterhouseCoopers in 1995, 1997, 1999 and 2006 in an attempt to show the evolution of the relationship between life sciences companies and the US Food and Drug Administration.

The 2010 survey was distributed electronically to potential respondents across the life sciences industry, including companies that develop biologic, drug and medical device products, and the findings represent respondents from 50 companies. PwC developed the survey, which was completed in the summer of 2010, in partnership with BIOCOM, the world’s largest regional life sciences association, located in San Diego. The purpose of the survey was to provide data for the FDA and industry to inform their interactions and decisions.



1. Improving America's Health V,, published October 2010

Michael Mentesana is the US R&D advisory services leader at PricewaterhouseCoopers. In this role, Mr Mentesana, who is based in New York, oversees R&D strategy and operations services for the firm’s pharmaceutical and life sciences clients. Website: Email:




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