Outlook A Key Part of the FDA Mission: Driving Innovation
Ensuring the safety of the food supply and the safety and effectiveness of drugs, de- vices and biologics has always been at the core of the FDA’s responsibility to protect the public health—and always will be. But what is oſten lost or neglected in
discussions about the FDA’s vigilance on behalf of consumer and patient safety is how this kind of oversight and regulation, when done right, can be a key driver of innovation throughout society. Whether it involves the develop- ment of some remarkable new drug or oversight of a particular product, the addition of rigorous regulatory sci- ence from the FDA helps to safeguard the safety and effectiveness of innova- tive new products; ensures that these scientific achievements quickly reach their full potential; and builds a pathway for ongoing innovation. Tat’s why we continue to adapt and change regulatory policies in response to—and in anticipa- tion of—scientific opportunities so that they can best be harnessed to improve health and medical care. Tere are many recent examples of
this thoughtful approach to innovative products. For instance, we have put in place a new breakthrough pathway to market for promising drugs that may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. Us- ing this new approach, we have already approved two treatments for rare types of cancer and one for hepatitis C. In a very different realm, another ex-
ample is mobile medical apps. We took a measured approach that promotes innovation when we finalized guidance related to these devices earlier this year.
Although many mobile apps pertain to health, the Center for Devices and Radiological Health intends to focus its oversight on a very small subset of those apps that are medical devices. We have called that subset “mobile medical apps” and we are approaching their regulatory oversight within a risk-based frame- work. We believe this approach will promote innovation while protecting patient safety by focusing on those apps that pose greater risk to patients.
Our regulation of software as a medical device is based on risk and functionality, and that function- ality should be treated the same regardless of the plat- form on which it is used.
As explained in the final mobile
medical application guidance, our regulation of soſtware as a medical de- vice—and a mobile app is soſtware—is based on risk and functionality, and that functionality should be treated the same regardless of the platform on which it is used. For example, an electrocardiog- raphy device—an ECG machine—that measures heart rhythms to help doc- tors diagnose patients is still an ECG machine regardless of whether it is the size of a bread box or the size of a smart- phone. Te risks it poses to patients and the importance of assuring for practi- tioners and patients that it is safe and effective are essentially the same. And, a few months ago, we authorized
for marketing four innovative gene- sequencing devices. Two of these products comprise a system that allows laboratories to develop clinical tests that can look at
a person’s genetic makeup and detect abnormalities that could be responsible for illness. Te FDA realized the innumerable uses of these systems from the outset, and rather than focusing on specific diseases or areas of the genome, we took a tool- based regulatory approach. We assessed whether the devices overall measure what they are intended to measure accurately, reliably and precisely so that there can be greater confidence in the test results. Tese types of genome sequencers represent a significant step forward in the ability to generate genomic information that may ultimately improve patient care. Each of the new medical products
we approve and usher to the market in- volves a balancing of risks and benefits, which is based on study and evalua- tion of hard data and the best available science. It is a huge responsibility that the FDA is charged with, nowhere more so than when dealing with unfolding technologies that offer enormous poten- tial—but that also may present real risks for people and their health. We know there will be new and
continuing challenges that arise with ad- ditional technological developments and advancements in science and medicine. Tis is why the FDA’s regulatory role in these emerging areas continues to develop as well, sometimes even as the technologies themselves are taking shape. But our goal remains constant—to
protect the public health through smart regulation that helps to enhance in- novation and ensure that new medi- cal technologies have real value to the people who will use them, and that they are used effectively and safely to address their needs.
Medical Manufacturing 2014 19
Margaret A. Hamburg, MD Commissioner
US Food and Drug Administration Washington, DC
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132 |
Page 133 |
Page 134 |
Page 135 |
Page 136 |
Page 137 |
Page 138 |
Page 139 |
Page 140 |
Page 141 |
Page 142 |
Page 143 |
Page 144 |
Page 145 |
Page 146 |
Page 147 |
Page 148 |
Page 149 |
Page 150 |
Page 151 |
Page 152 |
Page 153 |
Page 154 |
Page 155 |
Page 156 |
Page 157 |
Page 158 |
Page 159 |
Page 160 |
Page 161 |
Page 162 |
Page 163 |
Page 164 |
Page 165 |
Page 166 |
Page 167 |
Page 168 |
Page 169 |
Page 170 |
Page 171 |
Page 172 |
Page 173 |
Page 174 |
Page 175 |
Page 176 |
Page 177 |
Page 178 |
Page 179 |
Page 180 |
Page 181 |
Page 182 |
Page 183 |
Page 184 |
Page 185 |
Page 186 |
Page 187 |
Page 188 |
Page 189 |
Page 190 |
Page 191 |
Page 192 |
Page 193 |
Page 194 |
Page 195 |
Page 196 |
Page 197 |
Page 198 |
Page 199 |
Page 200 |
Page 201 |
Page 202 |
Page 203 |
Page 204 |
Page 205 |
Page 206 |
Page 207 |
Page 208 |
Page 209 |
Page 210 |
Page 211 |
Page 212 |
Page 213 |
Page 214 |
Page 215 |
Page 216